TABLE 1.
Effects of lycopene (from food, food extracts, or supplements) on BP, lipids, oxidative stress measures, immunoglobulins, and insulin growth factor in healthy populations or populations with CVD or CVD risk factors: data-extraction table1
Study (reference); country | NHMRC level of evidence/quality Ax | Study design | Study duration | Population | Intervention | Results of outcome of interest |
---|---|---|---|---|---|---|
Blood pressure | ||||||
Paran et al., 2009 (16); Beer Sheba, Israel | III-1/+ | Double-blinded, placebo-controlled, cross-over trial | 12 wk; no wash-out | n = 54; Moderate HPT and on HPT medication; Nonsmoker; Age: 61.4 ± 8.9 y (46–66 y); 26 Males; SBP 144.0 ± 10.0 mmHg; DBP 82.2 ± 7.8mmHg [mean ± SEM] | Dose: 1 capsule standardized tomato extract (15 mg lycopene/d) or Placebo capsule | SBP (mmHg):Baseline: 144.0 ± 10.0Postintervention: 130.4 ± 9.695% CI of difference: 12.1; – 6.3P-value: <0.001DBP (mmHg):Baseline: 82.2 ± 7.8Postintervention: 76.0 ± 7.895% CI of difference: 5.7; – 1.9P-value: <0.001[Mean ± SD] |
Massa et al., 2016 (17); Paraiba, Brazil | II/ɸ | Randomized, double-blinded, experimental and placebo-controlled study | 6 wk | n = 40; 21 men, 19 women; BMI: 25–35 kg/m2; HPT stage I or pre-HPT; consistent medication, exercise and dietWatermelon group: Age: 48.7 ± 1.9 y; BMI: 29.6 ± 1.1 k g/m2; WC: 98.1 ± 2.4 cmPlacebo group: Age: 47.4 ± 1.2 y; BMI: 28.2 ± 0.7 kg/m2; WC: 94.6 ± 2.5 cm [mean ± SE] | Dose: 6 g of watermelon extract (1.44 mg lycopene/d) | SBP decreased by 11.8 mmHg for the watermelon group while the placebo group showed no changes (P < 0.0001)DBP decreased by 6.9 mmHg for the watermelon group while the placebo group showed no changes (P < 0.001) |
Thies et al., 2012 (18); Aberdeen, United Kingdom | II/+ | Single-blinded randomized controlled trial | 16 wk (4-wk wash-out, 12-wk INT) | n = 225; 93 men, 132 women Sedentary or moderately active with signs of MS or moderate HPC; SBP <160 mmHg, DBP <99 mmHg; Age: 51.1 ± 0.8 y (40–65 y); BMI: 26.6 ± 0.5 kg/m2 (18.5–35 kg/m2); WC: 88.4 ± 1.3 cm; SBP: 130.0 ± 1.9 mmHg; DBP: 79.1 ± 1.3 mmHg [mean ± SEM] | Control diet low in tomato based foodsLycopene supplement group: 1 capsule/d containing 10 mg lycopene (70 mg lycopene/wk)High lycopene group: Diet high in tomato-based foods (70 mg lycopene/wk) | SBP (mmHg):Baseline: Lycopene: 127.9 ± 2.0, control 127.4 ± 1.9, P2-value: 0.516Postintervention (PI): Lycopene: 124.7 ± 3.0, control 127.1 ± 1.9, P3-value: 0.286DBP (mmHg):Baseline: Lycopene: 78.0 ± 1.2, control 77.0 ± 1.1, P2-value: 0.933PI: Lycopene: 77.0 ± 1.2, control 76.3± 1.1,P3-value: 0.227[Mean ± SEM]P2- Differences between groups at baselineP3- Changes in concentration from baseline Results are for lycopene and control group |
Ried et al., 2009 (19); Adelaide, Australia | II/+ | Randomized, placebo-controlled, 3-group-parallel trial | 6 mo [8-wk intervention (phase 1) with 4-wk wash-out, then 8-wk cross-over intervention (phase 2)] | n = 36Pre-HPT; Healthy adults; Not on antihypertensive medication; Age: 22–73 yTomato extract group: Age: 51.2 y (12.1); BMI: 26.2 kg/m2 (3.1); SBP: 128.2 mmHg (11.4); DBP: 79.1 mmHg (7.5) [median (IQR)]Groups were comparable at baseline | Group 1: 50 g dark chocolate/d (750 mg polyphenols)Group 2: 1 tomato extract capsule per day (15 mg lycopene)Group 3: Placebo | SBP (mmHg):Tomato, phase 1:Baseline, 128.2 ± 3.0 (11.4); Week 12, 129.3 ± 3.0 (11.8), P-value: 0.82Phase 2:Week 16, 131.0 ± 4.1 (13.6); Week 24, 127.6 ± 3.9 (8.1), P-value: 0.57DBP (mmHg):Tomato, phase 1:Baseline, 79.1 ± 1.9 (7.5); Week 12, 79.2 ± 2.2 (8.6), P-value: 0.98Phase 2:Week 16, 82.8 ± 2.8 (9.3); Week 24, 79.7 ± 3.7 (12.3), P- value: 0.91[Median (SE)] |
Gajendragadkar et al., 2014 (20); United Kingdom | III-1/+ | Prospective, randomized, double-blinded, placebo-controlled, parallel-group study | 8 wk | n = 72CVD group: n = 36 Stable CVD with statin therapy; 33 MalesLycopene group: Age: 67 ± 6 y; BMI: 28.6 ± 3.3 kg/m2Placebo group: Age: 68 ± 5 y; BMI: 28.4 ± 4.0 kg/m2HV group: n = 36Lycopene group: Age: 61 ± 13 y; BMI: 25.2 ± 2.8 kg/m2Placebo group: Age: 68 ± 5 y; BMI: 26.7 ± 3.6 kg/m225 Males [mean ± SD] | Dose: 7 mg of lycopene as capsule, once per day (Ateronon) (L)Placebo capsule (P) | Central SBP (mmHg):Day 1:Placebo (P): 129 (4), Lycopene (L):130 (3)Day 56:P: 127 (4), L: 126 (3)P-value: 0.6Central DBP (mmHg):Day 1:P: 77 (2), L: 82 (2)Day 56:P: 78 (3), L: 79 (2)P-value: 0.2P-value: for overall comparison in delta (day 56–day 1) values across placebo and lycopene-treated groups Results only reported for CVD group[Mean (SE)] |
Engelhard et al., 2006 (21); Beer Sheva, Israel | III-1/ɸ | Single-blinded, placebo-controlled trial | 16 wk (4-wk placebo; 8-wk intervention; 4-wk placebo) | n = 31Grade-1 HTN but otherwise healthy; Nonsmoker; Age: 30–70 y; BMI: 29.4 ± 0.8 kg/m2 [mean ± SE] | Dose: 1 capsule of Lyc-O-Mato per day (15 mg lycopene) | SBP (mmHg):Baseline: 145.0 ± 1.3, Week 4: 144.0 ± 1.1, Week 12: 134.0 ± 2*, Week 16: 144.0 ± 2.1DBP (mmHg):Baseline: 88.9 ± 1.4, Week 4: 87.4 ± 1.2, Week 12: 83.4 ± 1.2*, Week 16: 85.2 ± 2.5*Significant difference from placebo (P < 0.05)[Mean ± SE] |
Valderas-Martinez et al., 2016 (22); Valencia, Spain | III-1/ɸ | Open, prospective, randomized, cross-over, controlled-feeding trial | 14 wk (3-d wash-out, 1-d intervention, 1-mo wash- out, repeat for each intervention) | n = 4019 Males; No CVD, no medication, nonsmoker; Age: 28 ± 11 y; BMI: 23.30 ± 3.86 kg/m2 [mean ± SD] | Raw Tomato (RT): 7.0 g of raw tomato/kg of body weight (BW)Tomato Sauce (TS): 3.5g of tomato sauce/kg of BW Tomato Sauce with Olive Oil (TSOO): 3.5 g of tomato sauce with refined olive oil/kg of BWControl: 0.25 g of sugar dissolved in water/kg of BW | SBP (mmHg):Before InterventionRT: 120 ± 13, TS: 117 ± 13, TSOO: 120 ± 12, Control: 118 ± 9P-value: 0.135After intervention (6 h post)RT: 115 ± 11, TS: 115 ± 10, TSOO: 115 ± 12, Control: 115 ± 9 DBP (mmHg):Before interventionRT: 72.0 ± 9.5, TS: 73.0 ± 7.8, TSOO: 73.0 ± 8.1, Control: 71.0 ± 6.8P-value: 0.689After interventionRT: 70.0 ± 9.3, TS: 72.0 ± 9.6, TSOO: 70.0 ± 9.0, Control: 69.0 ± 8.0 significant between time in the interventionP-value of the ANOVA for repeated measures from the differences between interventions[Mean ± SD] |
Abete et al., 2013 (23); Pamplona, Spain | III-1/+ | Randomized, double-blind cross-over study | 10 wk (4-wk intervention, 2-wk wash-out, 4-wk cross-over intervention) | n = 32; Healthy subjects; 18 males; Age: 18–50 y; BMI: 18.5–29.9 kg/m2 | 160 g/d of either high-lycopene (27.2 mg lycopene/d) or low lycopene/commercial tomato sauce (12.3 mg lycopene/d) | SBP (mmHg):High-lycopene:Baseline: 107.4 ± 9.9; Endpoint:108.9 ± 10.1Commercial sauce:Baseline: 107.9 ± 12.5; Endpoint: 111.3 ± 12.1P-value: 0.429DBP (mmHg):High-lycopene:Baseline: 68.9 ± 6.8; Endpoint: 70.6 ± 7.8Commercial sauce:Baseline: 71.0 ± 9.4; Endpoint: 72.4 ± 9.3P-value: 0.826[Mean ± SD] |
Kim et al., 2011 (24); Seoul, Republic of Korea | II/+ | Randomized, double-blind, placebo-controlled intervention trial | 8 wk | n = 126; Healthy men; Age: 22–57 y; Frequently smoke cigarettes or consume alcohol; <3 servings vegetables and fruit per week; No history of chronic disease | Low dose: 6 mg lycopene/d via capsuleHigh dose: 15 mg lycopene/d via capsulePlacebo capsule | SBP (mmHg):PlaceboPre: 125 ± 1.96, Post: 124.4 ± 1.81Low dosePre: 123.5 ± 1.59, Post: 122.4 ± 1.69 |
High dose Pre: 126.0 ± 2.16, Post: 122.8 ± 1.78*[Mean ± SE]*P < 0.05 compared with baseline values in each group tested by paired t test | ||||||
Arranz et al., 2015 (25); Barcelona, Spain | III-1/- | Open, controlled, randomized, cross-over feeding trial | 6 d (3-d wash-out, 1-d intervention, 1-d wash-out, 1-d intervention) | n = 11; 6 Males; Age: 28 ± 3 y; BMI: 23 ± 2 kg/m2; Nonsmokers; No history of heart disease [mean ± SD] | Intervention 1: 750 g tomato juice (TJ) with 10% refined olive oilIntervention 2: 750 g TJ without refined olive oilSingle ingestion for both | SBP (mmHg):TJ with oilBaseline: 120.9 ± 17.5; 6 h: 116.0 ± 9.5Change (%): −1.9 ± 6.3TJ without oilBaseline: 117.5 ± 15.9; 6 h: 117.2 ± 15.3Change (%): −1.0 ± 10.3DBP (mmHg):TJ with oilBaseline: 69.3 ± 7.7; 6 h: 67.0 ± 7.1Change (%): −3.8 ± 12.4TJ without oilBaseline: 70.2 ± 10.5; 6 h: 69.5 ± 11.1Change (%): −0.4 ± 7.8[Mean ± SD] |
García-Alonso et al., 2012 (26); Murcia, Spain | II/ɸ | Randomized single-blind intervention trial | 2 wk | n = 22; Healthy women; Nonsmokers; no medication; Age: 35–55 y; BMI: 21–30 kg/m2 | Reference group: 500 mL tomato juice/d, ∼50 mg lycopene/dTest group: 500 mL tomato juice enriched with n–3 PUFAs/d | SBP (mmHg):Reference Juice:Day 0: 97.14 ± 3.06; Day 15: 105.86 ± 3.39Test juice:Day 0: 105.18 ± 2.63; Day 15: 106.36 ± 2.79DBP (mmHg):Reference juice:Day 0: 63.57 ± 2.37; Day 15: 65.71 ± 3.85Test juice:Day 0: 65.45 ± 2.82; Day 15: 64.09 ± 3.36[Mean ± SEM] |
Blood lipids | ||||||
Thies et al., 2012 (18); Aberdeen, United Kingdom | II/+ | Single-blinded randomized controlled trial | 16 wk (4-wk wash-out, 12-wk INT) | n = 225; 93 men, 132 women; Sedentary or moderately active with signs of MS or moderate HPC; SBP <160 mmHg, DBP <99 mmHg; Age: 51.1 ± 0.8 y (40-65 y); BMI: 26.6 ± 0.5 kg/m2 (18.5-35kg/m2); WC: 88.4 ± 1.3 cm; SBP: 130.0 ± 1.9 mmHg; DBP: 79.1 ± 1.3 mmHg [mean ± SEM] | Control diet low in tomato-based foodsLycopene supplement group: 1 capsule/d containing 10 mg lycopene (70 mg lycopene/wk)High lycopene group: Diet high in tomato-based foods (70 mg lycopene/wk) | Cholesterol (mg/dL):Baseline: L 215.39 ± 5.03, control 215.01 ± 4.25P2-value: 0.981, PI: L 212.69 ± 5.03; control 217.71 ± 6.57HDL-C (mg/dL):Baseline: L 64.68 ± 1.93, control 64.97 ± 1.95, P2 0.679, PI: L 64.97 ± 2.32; control 65.74 ± 1.55LDL-C (mg/dL):Baseline: L 131.09 ± 4.25, control 131.48 ± 3.87, P 2 0.782, PI: L 128.38 ± 4.25; control 132.64 ± 3.87 |
P 2 = Differences between groups at baseline[Mean ± SEM] | ||||||
Gajendragadkar et al., 2014 (27); United Kingdom | III-1/+ | Prospective, randomized, double-blinded, placebo-controlled, parallel-group study | 8 wk | n = 72CVD group: n = 36; Stable CVD with statin therapy; 33 MalesLycopene group: Age: 67 ± 6 y; BMI: 28.6 ± 3.3 kg/m2Placebo group: Age: 68 ± 5 y; BMI: 28.4 ± 4.0 kg/m2HV group: n = 36Lycopene group: Age: 61 ± 13 y; BMI: 25.2 ± 2.8 kg/m2Placebo group: Age: 68 ± 5 y; BMI: 26.7 ± 3.6 kg/m225 Males [mean ± SD] | Dose: 7 mg of lycopene as capsule, once per day (Ateronon) (L)Placebo capsule (P) | HDL-C (mg/dL):Day 1:Placebo (P): 57.23 (5.41), Lycopene (L): 46.40 (1.93)Day 56:P: 56.84 (6.19), L: 45.24 (2.32)P-value: 0.7LDL-C (mg/dL):Day 1: P: 93.19 (5.80), L: 93.19 (5.41)Day 56: P: 83.53 (5.41), L: 93.19 (4.64)P-value: 0.1P-value: for overall comparison in delta (day 56–day 1) values across placebo and lycopene treated groupsResults only reported for CVD group[Mean (SE)] |
Engelhard et al., 2006 (21); Beer Sheva, Israel | III-1/ɸ | Single-blinded, placebo-controlled trial | 16 wk (4-wk placebo; 8-wk intervention; 4-week placebo) | n = 31; Grade-1 HTN but otherwise healthy; Nonsmoker; Age: 30–70 y; BMI: 29.4 ± 0.8 kg/m2 [mean ± SE] | Dose: 1 capsule of Lyc-O-Mato per day (15 mg lycopene) | TGs (mg/dL):Baseline: 201.8 ± 15.8, Week 4: 177.7 ± 17.3, Week 12: 182.5 ± 18.0Total cholesterol (mg/dL):Baseline: 213.0 ± 6.4, Week 4: 199.2 ± 6.5, Week 12: 207.4 ± 6.5HDL-C (mg/dL):Baseline: 43.7 ± 1.6, Week 4: 41.3 ± 1.80, Week 12: 43.6 ± 1.8LDL-C (mg%):Baseline: 126.2 ± 6.0, Week 4: 121.9 ± 6.2, Week 12: 128.0 ± 6.0[Mean ± SE] |
Abete et al., 2013 (28); Pamplona, Spain | III-1/+ | Randomized, double-blind cross-over study | 10 wk (4-wk intervention, 2-wk wash-out, 4-wk cross-over intervention) | n = 32; Healthy subjects; 18 males; Age: 18–50 y; BMI: 18.5–29.9 kg/m2 | 160 g/d of either high-lycopene (27.2 mg lycopene/d) or low lycopene/commercial tomato sauce (12.3 mg lycopene/d) | LDL-C (mg/dL)High-lycopene:Baseline: 118.6 ± 35.1; Endpoint: 114.4 ± 35.8Commercial sauce:Baseline: 118.1 ± 36.2; Endpoint: 115.6 ± 35.5P value: 0.736HDL-C (mg/dL)High-lycopene:Baseline: 60.5 ± 13.7; Endpoint: 65.0 ± 14.1 |
Commercial sauce:Baseline: 64.7 ± 14.1; Endpoint: 64.2 ± 15.2P-value: 0.486TGs (mg/dL)High-lycopene:Baseline: 79.6 ± 33.1Endpoint: 84.3 ± 37.9Commercial sauce:Baseline: 82.2 ± 32.9Endpoint: 89.0 ± 41.4P- value: 0.839[Mean ± SD] | ||||||
Valderas-Martinez et al., 2016 (14); Valencia, Spain | III-1/ɸ | Open, prospective, randomized, cross-over, controlled-feeding trial | 14 wk (3-d wash-out, 1-d intervention, 1-mo wash-out, repeat for each intervention) | n = 40; 19 Males; No CVD, no medication, nonsmoker; Age: 28 ± 11 y; BMI: 23.30 ± 3.86 kg/m2 [mean ± SD] | Raw Tomato (RT): 7.0 g of raw tomato/kg of body weight (BW)Tomato Sauce (TS): 3.5 g of tomato sauce/kg of BWTomato Sauce with Olive Oil (TSOO): 3.5 g of tomato sauce with refined olive oil/kg of BWControl: 0.25 g of sugar dissolved in water/kg of BW | Total-C (mg/dL):Before intervention: RT: 167 ± 28, TS: 170 ± 29, TSOO: 167 ± 23, Control: 168 ± 16P 3 value: 0.005After intervention (6 h post): RT: 160 ± 28, TS: 162 ± 26, TSOO: 158 ± 22, Control: 167 ± 13HDL-C (mg/dL):Before intervention: RT: 52.0 ± 11.2, TS: 52.0 ± 11.8, TSOO: 52.0 ± 11.3 P 3 value: 0.404Control: 50.0 ± 12.7After intervention: RT: 53.0 ± 11.1, TS: 53.0 ± 12.4, TSOO: 55.0 ± 13.3*, Control: 50.0 ± 11.9LDL-C (mg/dL):Preintervention: RT: 95.0 ± 19.6, TS: 96.0 ± 22.6, TSOO: 95.0 ± 20.5, Control: 95.0 ± 13.9P 3 value: 0.184Postintervention: RT: 92.0 ± 19.0, TS: 92.0 ± 18.2*, TSOO: 93.0 ± 18.9, Control: 95.0 ± 11.8TGs (mg/dL):Preintervention: RT: 84.0 ± 54.7, TS: 86.0 ± 42.0, TSOO: 83.0 ± 36.5, Control: 86.0 ± 23.8P 3 value: 0.002Postintervention: RT: 62.0 ± 34.8, TS: 57.0 ± 22.7, TSOO: 68.0 ± 31.7, Control: 83.0 ± 31.6 |
*Significant differences significant between time in the interventionP 3 = value of the ANOVA for repeated measures from the differences between interventions[Mean ± SD] | ||||||
Arranz et al., 2015 (29); Barcelona, Spain | III-1/- | Open, controlled, randomized, cross-over feeding trial | 6 d (3-d wash-out, 1-d intervention, 1-d wash-out, 1-d intervention) | n = 11; 6 Males; Age: 28 ± 3 y; BMI: 23 ± 2 kg/m2; Nonsmokers; No history of heart disease [mean ± SD] | Intervention 1: 750 g tomato juice (TJ) with refined olive oilIntervention 2: 750 g TJ without refined olive oilSingle ingestion | TGs (mg/dL):TJ with oilBaseline: 81.3 ± 17.9; 6 h: 83.7 ± 37.2Change (%): 3.7 ± 43.9TJ without oilBaseline: 87.5 ± 28.7; 6 h: 69.7 ± 18.6*Change (%): −21.3 ± 18.4Total cholesterol (mg/dL)TJ with oilBaseline: 160 ± 27.6; 6 h: 150 ± 22.4*Change (%): −6.2 ± 5.1TJ without oilBaseline: 160 ± 24.8; 6 h: 153 ± 23.2*Change (%): −5.8 ± 4.4LDL-C (mg/dL):TJ with oilBaseline: 102 ± 17.9; 6 h: 96.4 ± 16.3*Change (%): −5.5 ± 7.2TJ without oilBaseline: 100 ± 16.0; 6 h: 99.3 ± 16.3Change (%): −1.0 ± 7.4HDL-C (mg/dL)TJ with oilBaseline: 41.6 ± 10.9; 6 h: 38.9 ± 10.9*Change (%): −2.7 ± 2.8TJ without oilBaseline: 42.5 ± 11.1; 6 h: 40.5 ± 11.1*Change (%): −2.0 ± 2.9*Statistically different from baseline[Mean ± SD] |
García-Alonso et al., 2012 (26); Murcia, Spain | II/ɸ | Randomized single-blind intervention trial | 2 wk | n = 22 Healthy women; Nonsmokers; no medications; Age: 35–55 y; BMI: 21–30 kg/m2 | Reference group: 500 mL tomato juice/d, ∼50 mg lycopene/dTest group: 500 mL tomato juice enriched with n–3 PUFAs/d | Total cholesterol (mg/dL):Reference juice:Day 0: 201.86 ± 12.45Day 15: 202.29 ± 8.98Test juice:Day 0: 192.64 ± 10.10Day 15: 202.27 ± 10.28HDL-C (mg/dL):Reference juice:Day 0:76.00 ± 5.36Day 15: 79.43 ± 5.51TEST JUICEDay 0: 68.91 ± 4.61Day 15: 73.73 ± 4.99LDL-C (mg/dL):Reference juice:Day 0: 115.21 ± 11.39Day 15:112.29 ± 10.36Test juice:Day 0:110.55 ± 8.60Day 15: 115.36 ± 5.45TGs (mg/dL):Reference juice:Day 0: 53.00 ± 4.68Day 15: 52.86 ± 3.88Test juice:Day 0: 65.91 ± 8.51Day 15: 65.45 ± 7.93Day 15: 0.27 ± 0.001*[Mean ± SEM]*Significantly different from day 0 within treatment group |
McEneny et al., 2013 (30); Aberdeen, United Kingdom | II/+ | Single-blinded, randomized controlled trial | 16 wk (4-wk wash-out, 12-wk intervention) | n = 234; Signs of MS or moderate HPC; No CVD; No medication; Age: 40–65 y; BMI: 18.5–35 kg/m2 | Lycopene-rich diet group: 224–350 mg lycopene/wk from a diet high in tomato-based foodsLycopene supplement group: 70 mg lycopene/wkControl: <10 mg lycopene/wk | HDL2:Baseline: control: 0.26 (0.03), supplement: 0.70 (0.18)P-value: 0.023Postintervention:control: 0.20 (0.04), supplement: 1.54 (0.27)P < 0.001HDL3:Baseline: control: 0.03 (0.01), supplement: 0.05 (0.01)P-value: 0.092Postintervention: control: 0.04 (0.01), 0.13 (0.02)P < 0.001[Mean (SEM)] |
Jacob et al., 2008 (31); Jena, Germany | II/- | Randomized intervention study | 4 wk (2-wk wash-out, 2-wk intervention) | n = 24 Healthy volunteers; Nonsmokers; Age: 23 ± 2 y; BMI: 21.5 ± 2.8 kg/m2 [mean ± SD] | Group L: 250 mL tomato juice twice daily (20.9 mg lycopene/d)Group LC: Same tomato juice enriched with vitamin C | Cholesterol (mg/dL):Lycopene group (L)T-2: 157.1 ± 27.6; T0: 157.6 ± 40.8; T±2: 153.2 ± 30.8P-value: 0.008*Lycopene/Vitamin C Group (LC)T-2: 156.6 ± 28.3; T0: 153.4 ± 29.3; T±2: 147.4 ± 31.9P -value: 0.002*P- values for statistical difference between the groups in T+2 (ANOVA)T-2 = Baseline, T0 = Post-wash-out, T+2 = Postintervention[Mean ± SD] |
Silaste et al., 2007 (32); Oulu, Finland | III-1/- | Randomized cross-over controlled trial | 8 wk (2-wk baseline period, 3-wk low tomato diet, 3-wk high lycopene diet) | n = 21; 5 Males; Healthy; nonsmoker; Age: 20–49 y (mean: 30 y); BMI: 23.5 ± 2.3 kg/m2; 7 women used oral contraceptives [mean ± SD] | High tomato: 400 mL tomato juice (5.9 mg lycopene) AND 30g tomato ketchup (12.4 mg lycopene)Low tomato: No tomato products allowed | Total cholesterol (mmol/L):Baseline: 4.43 (0.64)P-value: 0.005Low-Tomato: 4.50 (0.63)P-value: 0.002High-Tomato: 4.19 (0.78)LDL-C (mmol/L):Baseline: 2.44 (0.51)P-value: 0.002Low-Tomato: 2.56 (0.56)P-value: 0.0002High-Tomato: 2.18 (0.62)P-value not specified[Mean (SD)] |
Misra et al., 2006 (33); New Delhi, India | II/ɸ | Randomized controlled trial | 6 mo | n = 41; Postmenopausal women aged <60 y, cessation of menses >1 y ago, or >6 mo; FSH level >40 u/L; NonsmokerHRT group: n = 21; Age: 46.2 y; BMI: 25.3 kg/m2LycoRed group: n = 22; Age: 46.4 y; BMI: 25.8 kg/m2No statistically significant differences between groups | Group 1: Oral HRT dailyGroup 2: 2 x LycoRed softules (containing 2000 μg lycopene each) daily | Total cholesterol (mg/dL):Baseline: 215.1 ± 31.3; 3 Mo: 189.2 ± 27.2; 6 Mo: 161.5 ± 34.3P-value: 0.0001HDL-C (mg/dL):Baseline: 47.6 ± 1.9; 3 Mo: 53.7 ± 7.8; 6 Mo: 59.1 ± 7.4P-value: 0.001LDL-C (mg/dL)Baseline: 132.0 ± 32.8; 3 Mo: 116.7 ± 24.7; 6 Mo: 107.8 ± 19.6P-value: 0.001VLDL-C (mg/dL)Baseline: 25.6 ± 1.1; 3 Mo: 26 ± 3.5; 6 Mo: 25.7 ± 4.2P-value: 0.92TG (mg/dL)Baseline: 123.0 ± 28.3; 3 Mo: 127.8 ± 21.6; 6 Mo: 134.3 ± 16.9P-value: 0.001Significant difference in mean levels between the 2 groups at 0 and 6 moResults reported are for LycoRed group.[Mean (SD)] |
Collins et al., 2004 (14); Beltsville, MD, USA | III-2/- | Diet-controlled, repeated-measures, cross-over controlled trial | 19 wk (2-wk washout, 3-wk intervention, 4-wk wash-out, repeated for each intervention) | n = 10; 5 Males; Healthy, nonsmokers; Mean age: 50 y; Mean BMI: 27.7 kg/m2 | Watermelon juice: 20.1 mg lycopene/d from watermelon juiceTomato juice: 18.4 mg lycopene/d from tomato juiceControl: no added lycopene | TGs (mg/dL):Depletion: 185.9 ± 16.9Postintervention (PI): Control: 181.7 ± 16.9; Watermelon: 198.9 ± 18.3; Tomato: 174.7 ± 15.6HDL-C (mg/dL):Depletion: 56.9 ± 5.15PI: Control: 58.65 ± 4.31; Watermelon: 58.00 ± 5.96; Tomato: 59.38 ± 4.55Total cholesterol (mg/dL):Depletion: 220.9 ± 9.5PI: Control: 223.4 ± 7.9; Watermelon: 224.6 ± 8.2; Tomato: 233.6 ± 6.2Results reported on group 1 [Mean ± SE] |
Cuevas-Ramos et al., 2013 (3); Tlalpan, Mexico | II/+ | Randomized, single-blinded, controlled clinical trial | 6 wk (2-wk run-in, 4-wk intervention) | n = 52; 11 Males; Age: 18–65 y; Low HDL-C, normal TGTomato group: n = 26; Age: 43.4 ± 15.5 y; BMI: 27.1 ± 5.0 kg/m2Control group: n = 26 (24?); Age: 40.3 ± 16.0 y; BMI: 27.1 ± 4.0 kg/m2 [mean ± SD] | Dose: 300 g Roma tomatoes (∼2)/dControl: 300 g raw cucumber/d | TGs (mg/dL):Tomato, Baseline: 113.4 ± 46.4; Final: 122.7 ± 21.8P-value: 0.18Control, Baseline: 107.5 ± 36.3; Final: 106.9 ± 41.5P-value: 0.89Cholesterol (mg/dL):Tomato, Baseline: 165.9 ± 44.7; Final: 169.7 ± 39.7P-value: 0.62Control, Baseline: 162.5 ± 31.0; Final: 159.9 ± 33.2P-value: 0.41HDL-C (mg/dL):Tomato, Baseline: 36.5 ± 7.5; Final: 41.6 ± 6.9 *P-value: <0.0001Control, Baseline: 36.8 ±7.2; Final: 35.8 ± 7.3P value: 0.08LDL-C (mg/dL):Tomato, Baseline: 108.1 ± 38.1; Final: 104.5 ± 31.0P-value: 0.63Control, Baseline: 103.2 ± 28.0; Final: 104.3 ± 30.0P value: 0.71*P < 0.05 considered significant[Mean ± SD] |
Tsitsimpikou et al., 2014 (34); Crete, Greece | III-2/+ | Parallel, controlled trial (randomization unclear) | 8 wk | n = 27; Patients with MS; High TG, Low HDL-C, High BP; High fasting blood glucose or on medicationTomato group: n = 15; 13 Males; Age: 53.5 ± 9.8 yControl group: n = 12; 11 Males; Age: 56.6 ± 10.2 y [mean ± SD] | Regular diet supplemented with tomato juice 4 times/wkDose: TJ with 2.51 mg lycopene per 100 mL | TC baseline (mg/dL): 212 ± 24.9; TCsupplement (mg/dL): 208 ± 33.3P-value: 0.889TG baseline (mg/dL): 284 ± 68.3; TG supplement (mg/dL): 287 ± 77.1P-value: 0.695HDL-C baseline (mg/dL): 41.0 ± 7.81; HDL-C supplement (mg/dL): 44.4 ± 6.72P-value: 0.049*LDL-C baseline (mg/dL): 144 ± 38.9; LDL-C supplement (mg/dL): 123 ± 30.5P-value: <0.001*[Mean ± SD] |
Devaraj et al., 2008 (13); Sacramento, CA, USA | II/+ | Double-blind, randomized, placebo-controlled trial | 10 wk (2-wk wash-out, 8-wk intervention) | n = 82; Healthy subjects; 19 Males; Mildly elevated cholesterol; nonsmokers, <30 mL alcohol/d; >40 y of age | 6.5 mg, 15 mg, or 30 mg/d via lycopene capsulesPlacebo capsule | Serum total cholesterol (mg/dL):Placebo: Visit A: 208.2 ± 71.9; Visit B: 205.7 ± 68.3; Visit C: 204.7 ± 30.2Lycopene 6.5 mg: Visit A: 203.8 ± 25.6; Visit B: 205.1 ± 27.1; Visit C: 203.3 ± 27.2Lycopene 15 mg: Visit A: 197.6 ± 20.2; Visit B: 207.3 ± 22.4; Visit C: 210.4 ± 19.9Lycopene 30 mg: Visit A: 194.6 ± 20.4; Visit B: 199.2 ± 22.5; Visit C: 201.5 ± 23.0LDL-C (mg/dL):Placebo: Visit A: 124.8 ± 30.9; Visit B: 124.7 ± 24.6; Visit C: 123.9 ± 27.0Lycopene 6.5 mg: Visit A: 127.9 ± 22.8; Visit B: 129.4 ± 19.4; Visit C: 125.1 ± 21.3Lycopene 15 mg: Visit A: 120.0 ± 21.6; Visit B: 131.4 ± 19.3; Visit C: 125.4 ± 21.4Lycopene 30 mg: Visit A: 120.9 ± 19.5; Visit B: 121.4 ± 24.7; Visit C: 123.4 ± 23.0HDL-C (mg/dL):Placebo: Visit A: 56.8 ± 9.2; Visit B: 56.7 ± 9.2; Visit C: 56.9 ± 10.2Lycopene 6.5 mg: Visit A: 54.4 ± 13.9; Visit B: 55.5 ± 11.2; Visit C: 56.2 ± 10.9Lycopene 15 mg: Visit A: 64.8 ± 1.3; Visit B: 62.6 ± 13.2; Visit C: 66.7 ± 15.7Lycopene 30 mg:Visit A: 56.5 ± 19.8; Visit B: 56.5 ± 17.8; Visit C: 55.8 ± 16.8Serum triacylglycerol (mg/dL)Placebo: Visit A: 94.8 ± 27.4; Visit B: 99.6 ± 40.8; Visit C: 103.5 ± 44.5Lycopene 6.5 mg: Visit A: 91.1 ± 36.6; Visit B: 87.7 ± 36.9; Visit C: 95.9 ± 36.3Lycopene 15 mg: Visit A: 88.1 ± 24.3; Visit B: 87.2 ± 23.8; Visit C: 90.1 ± 39.4Lycopene 30 mg: Visit A: 107.5 ± 45.9; Visit B: 100.7 ± 45.8; Visit C: 100.9 ± 45.6No significant effects of time or treatment[Mean ± SD] |
Massa et al., 2016 (23); Paraíba, Brazil | II/+ | Randomized, double-blind, placebo-controlled trial | 6 wk | n = 43; Dyslipidemic; Age: 47.22 ± 6.5 y, between 20–60 y; No lipid-lowering medicationExperimental Group: n = 22; Age: 47.1 ± 7.5 y; 11 MalesControl Group: n = 21; Age: 47.33 ± 5.5 y; 11 Males [mean ± SD] | Dose: 6 g of watermelon extract (1.44 mg/lycopene), once per day | Sufficient outcome data not reportedSignificant reduction in TC and LDL-CTGs: –38.05 mg/dL |
Burton-Freeman et al., 2012 (35); Bedford Park, IL, USA | II/+ | Single-center, randomized, cross-over, 2-arm, 2-sequence, placebo-controlled, 360-min postprandial trial | 360 min | n = 25; Healthy; nonsmokers; hs-CRP <1.0 mL/L; 13 Males; Age: 27 ± 8 y; BMI: 22, >19 and <24 kg/m2 [mean ± SD] | Tomato-containing mealDose: ∼85 g tomato paste | TGs (mg/dL): Tomato: 122.6 ± 11.3; Control: 111.7 ± 11.3P -value: 0.14[LSM ± SEM] |
Samaras et al., 2014 (25); Larissa, Greece | III-2/+ | Parallel controlled trial (randomization unclear) | 8 wk | n = 27; Ultra-marathon runners; nonsmokers; no medical history of HT; Tomato juice: 13 Males, 2 Females; Age: 44.9 ± 8.53 y; BMI: 24.1 ± 2.46 kg/m2; Control: 12 Males; Age: 46.6 ± 15.3 y; BMI: 24.3 ± 1.56 kg/m2 [mean ± SD] | Tomato juice dailyDose: Amount required to match subjects with usual carbohydrate supplementation (unspecified amount) | TCbaseline (mg/dL): 207 ± 55.2; TCSupplement (mg/dL): 181 ± 23.1P-value: 0.048*TGBaseline(mg/dL): 84.9 ± 41.3; TGSupplement(mg/dL): 87.1 ± 29.4P-value: 0.823HDL-CBasline(mg/dL): 80.7 ± 18.70; HDL-CSupplement(mg/dL): 80.5 ± 9.81P-value: 0.954LDL-CBaseline(mg/dL): 110.0 ± 41.20; LDL-CBaseline(mg/dL): 82.8 ± 22.0P-value: 0.011*[Mean ± SD] All values reported on tomato supplementation group |
Blum et al., 2006 (36); Haifa, Israel | III-2/- | Nested case-controlled study (no randomization) | 4 wk | n = 98; Healthy >18 y; Age: 45.5 ± 14.1 y; Tomato group: 16 Males; Control group: 16 Males | Regular diet supplemented with tomatoDose: 300 g tomato products (including TS, TJ, FT, tomato soup) per day | Total cholesterol (mg/dL):Before: 207.5 ± 44.3; Postintervention: 204.1 ± 45.1P-value: 0.68TGs (mg/dL):Before: 170.8 ± 85.4; Postintervention: 167.4 ± 99.4P-value: 0.98HDL-C (mg/dL):Before: 46.1 ± 10.6; Postintervention: 53.4 ± 13.3P-value: 0.03*LDL-C (mg/dL):Before: 127.7 ± 41.8; Postintervention: 119.1 ± 41.7P-value: 0.57VLDL-C (mg/dL):Before: 34.2 ± 17.1; Postintervention: 32.9 ± 19.4P-value: 0.78[Mean ± SD]*Results reported on intervention group |
Oxidative stress | ||||||
Abete et al., 2013 (28); Pamplona, Spain | III-1/+ | Randomized, double-blind cross-over study | 10 wk (4-wk intervention, 2-wk wash-out, 4-wk cross-over intervention) | n = 32; Healthy subjects; 18 males; Age: 18–50 y; BMI: 18.5-29.9 kg/m2 | 160 g/d of either high-lycopene (27.2 mg lycopene/d) or low lycopene/commercial tomato sauce (12.3 mg lycopene/d) | TAC (mM Trolox):High-lycopene: Baseline:1.3 ± 0.8, Endpoint: 1.5 ± 0.8Commercial sauce: Baseline:1.4 ± 0.6, Endpoint: 1.3 ± 0.6P-value:0.058Oxidized LDL-C (U/L):High-lycopene: Baseline:45.7 ± 18.7, Endpoint:40.4 ± 15.4Commercial sauce: Baseline: 43.9 ± 18.0, Endpoint: 44.2 ± 17.4P-value: 0.080GPx activity (nmol/min/mL):High-lycopene: Baseline: 158.5 ± 90.5, Endpoint: 156.8 ± 85.1Commercial sauce: Baseline: 152.1 ± 69.5, Endpoint: 150.9 ± 68.0P-value: 0.615MDA (equivalents):High-lycopene: Baseline: 0.6 ± 0.3, Endpoint: 0.6 ± 0.3Commercial sauce: Baseline: 0.6 ± 0.2, Endpoint: 0.5 ± 0.3P-value: 0.899[Mean ± SD] |
Silaste et al., 2007 (37); Oulu, Finland | III-1/- | Randomized cross-over controlled trial | 8 wk (2-wk baseline period, 3-wk low tomato diet, 3-wk high lycopene diet) | n = 21; 5 Males; Healthy; nonsmoker; Age: 20–49 y (mean: 30 y); BMI: 23.5 ± 2.3 kg/m2; 7 women used oral contraceptives [mean ± SD] | High tomato: 400 mL tomato juice (5.9 mg lycopene) AND 30 g tomato ketchup (12.4mg lycopene) dailyLow tomato: No tomato products allowed | LDL-C oxidation– EO6 binding (RLU/ms)Baseline: 107978 ± 38478; Low-Tomato: Value not reported; High-Tomato: 93220 ± 40732P -value: 0.02[Mean ± SD] |
Kim et al., 2011 (38); Seoul, Republic of Korea | II/+ | Randomized, double-blind, placebo-controlled intervention trial | 8 wk | n = 126; Healthy men; Age: 22–57 y; Frequently smoke cigarettes or consume alcohol; <3 servings vegetables and fruit per week; No history of chronic disease | Low dose: 6 mg lycopene/d via capsuleHigh dose: 15 mg lycopene/d via capsulePlacebo | Tail DNA (%):Placebo: Pretreatment: 10.7 ± 0.33; Post-treatment: 9.87 ± 0.37Low-dose: Pretreatment: 10.8 ± 0.55; Post-treatment: 9.39 ± 0.38*High-dose: Pretreatment: 11.2 ± 0.52; Post-treatment: 9.30 ± 0.36LDL-C particle size (nm):Placebo: Pretreatment: 23.76 ± 0.10; Post-treatment: 23.79 ± 0.10Low-dose: Pretreatment: 23.63 ± 0.10; Post-treatment: 23.74 ± 0.10High-dose: Pretreatment: 23.80 ± 0.10; Post-treatment: 23.93 ± 0.09 |
*[Mean ± SE]*P < 0.05 compared with baseline values in each group tested by paired t test = P < 0.001 compared with baseline values in each group tested by paired t test | ||||||
Stangl et al., 2011 (39); Berlin, Germany | III-1/ɸ | Randomized cross-over, controlled trial | 4 wk (1-wk intervention, 2-wk wash-out, 1-wk cross-over intervention) | n = 19; Healthy postmenopausal women, nonsmoking, no CVD risk factors; Age: 58.9 ± 6.3 y; BMI: 25.0 ± 3.3 kg/m2; SBP: 115 ± 10 mmHg; DBP: 70 ± 6 mmHg [mean ± SD] | Intervention: Buttered roll with tomato puree (70 g, 46.2 mg lycopene) consumed daily for 7 dControl: Buttered roll without tomato puree consumed daily for 7 d | FMD (%):Baseline: 7.8 ± 3.3; 24h: 8.2 ± 2.8; 7d: 8.3 ± 2.7Prior to control: 7.7 ± 3.2; 24h: 8.6 ± 3.5; 7d: 8.2 ± 2.7[Mean ± SEM] |
Jacob et al., 2008 (31); Jena, Germany | II- | Randomized intervention study | 4 wk (2-wk wash-out, 2-wk intervention) | n = 24 Healthy volunteers; Nonsmokers; Age: 23 ± 2 y; BMI: 21.5 ± 2.8 kg/m2 [mean ± SD] | Group L: 250 mL tomato juice twice daily (20.9 mg lycopene/d)Group LC: Same tomato juice enriched with vitamin C | TGs (mg/dL):L: T-2: 123.3 ± 74.9; T0: 105.7 ± 43.5; T±2: 153.2 ± 30.8; LC: T-2: 82.5 ± 36.3; T0: 91.1 ± 34.6; T±2:81.3 ± 33.5P-value: 0.072FRAP (mmol/L):L: T-2: 0.84 ± 0.18; T0: 0.82 ± 0.16; T±2: 0.85 ± 0.20; LC: T-2: 0.79 ± 0.27; T0: 0.83 ± 0.23; T±2: 0.82 ± 0.25P-value: 0.667TBARS (μmol MDA/L):L: T-2: 0.55 ± 0.10; T0: 0.54 ± 0.10; T±2: 0.53 ± 0.10; LC: T-2: 0.60 ± 0.14; T0: 0.56 ± 0.14; T±2: 0.50 ± 0.09P-value: 0.271TNF-ɑ (ng/L):L: T-2: 6.97 ± 4.69; T0: 6.01 ± 5.27; T±2: 3.45 ± 1.32; LC: T-2: 2.93 ± 1.49; T0: 3.35 ± 2.23; T±2:3.28 ± 0.97P-value: 0.609P-values for statistical difference between the groups in T+2 (ANOVA)[Mean ± SD] |
García-Alonso et al., 2012 (26); Murcia, Spain | II/ɸ | Randomized single-blind intervention trial | 2 wk | n = 22; Healthy women; Nonsmokers; no medication; Age: 35–55 y; BMI: 21-30 kg/m2 | Reference group: 500 mL tomato juice/d, ∼50 mg lycopene/dTest group: 500 mL tomato juice enriched with n–3 PUFAs/d | TEAC (nM Trolox):Reference juice: Day 0: 2.17 ± 0.27; Day 15: 2.90 ± 0.23Test juice: Day 0: 2.50 ± 0.19; Day 15: 2.41 ± 0.25FRAP (mM Trolox):Reference juice: Day 0: 0.22 ± 0.02; Day 15: 0.24 ± 0.10Test juice: Day 0: 0.22 ± 0.01; Day 15: 0.27 ± 0.001*MDA (μM MDA):Reference juice: Day 0: 0.62 ± 0.06; Day 15: 0.54 ± 0.06Test juice: Day 0: 0.75 ± 0.11; Day 15: 0.61 ± 0.03*Significantly different from day 0 within treatment group [Mean ± SEM] |
Burton-Freeman et al., 2012 (35); Bedford Park, IL, USA | II/+ | Single-center, randomized, cross-over, 2-arm, 2-sequence, placebo-controlled, 360-min postprandial trial | 360 min | n = 25 Healthy; nonsmokers; hs-CRP <1.0 mL/L; 13 Males; Age: 27 ± 8 y; BMI: 22, >19, and <24 kg/m2 [mean ± SD] | Tomato-containing mealDose: ∼85 g tomato paste | OxLDL-C (U/L):Tomato: 72.0 ± 4.3, Control: 77.8 ± 4.4P-value: 0.02IL-6 (pg/mL):Tomato: 2.2 ± 0.3, Control: 2.6 ± 0.3P-value: 0.19[LSM ± SEM] |
Tsitsimpikou et al., 2014 (34); Crete, Greece | III-2/+ | Parallel, controlled trial (randomization unclear) | 8 wk | n = 27; Patients with MS; High TG, Low HDL-C, High BP; High fasting blood glucose or on medicationTomato group: n = 15, 13 Males; Age: 53.5 ± 9.8 yControl group: n = 12, 11 Males; Age: 56.6 ± 10.2 y [mean ± SD] | Regular diet supplemented with tomato juice 4 times/wk; unspecified amountDose: TJ with 2.51 mg lycopene per 100 mL | IL-6baseline (pg/mL): 38.1± 22.2; IL-6supplement (pg/mL): 35.19 ± 18.7P -value: 0.126TNF-ɑbaseline (pg/mL): 35.5 ± 21.9; TNF -ɑ supplement (pg/mL): 28.0 ± 15.6P -value: 0.021[Mean ± SD] |
Devaraj et al., 2008 (13); Sacramento, CA, USA | II/+ | Double-blind, randomized, placebo-controlled trial | 10 wk (2-wk wash-out, 8-wk intervention) | n = 82 Healthy subjects; 19 Males; Mildly elevated cholesterol; nonsmokers, <30 mL alcohol/d; >40 y of age | 6.5 mg, 15 mg, or 30,mg/d via lycopene capsulesPlacebo capsule | LDL-C oxidation rate (nmol/min):Placebo: Visit A: 3.83 ± 1.8; Visit B: 4.03 ± 1.7; Visit C: 3.68 ± 1.6Lycopene 6.5 mg: Visit A: 4.59 ± 2.04; Visit B: 4.35 ± 1.81; Visit C: 4.17 ± 1.76Lycopene 15 mg: Visit A: 4.42 ± 2.15; Visit B: 4.67 ± 1.79; Visit C: 4.04 ± 1.89Lycopene 30 mg: Visit A: 3.74 ± 1.64; Visit B: 4.05 ± 1.66; Visit C: 3.80 ± 1.70LDL-C lag time (min):Placebo: Visit A: 67.8 ± 11.3; Visit B: 67.8 ± 11.6; Visit C: 69.0 ± 15.6Lycopene 6.5 mg: Visit A: 64.0 ± 9.80; Visit B: 66.1 ± 12.7; Visit C: 67.6 ± 13.6Lycopene 15 mg: Visit A: 65.6 ± 9.40; Visit B: 65.4 ± 9.9; Visit C: 63.7 ± 12.8Lycopene 30 mg: Visit A: 70.6 ± 9.1; Visit B: 72.5 ± 9.9; Visit C: 68.6 ± 18.0No significant effects of time or treatment[Mean ± SD] |
Rao and Shen, 2002 (40); Toronto, Canada | III-1- | Randomized, cross-over design | 24 wk (2-wk wash-out, 2-wk treatment period, repeated for each of the 6 treatments) | n = 12; 6 Males; Nonsmokers; Age: 31 ± 2.7 y; Weight: 64.6 ± 3.7 kg; BMI: 22.6 ± 1.2 kg/m2 [mean ± SEM] | Tomato sauce: 5, 10, 20 mg lycopene as tomato ketchup dailyTomato supplement: 5, 10, 20 mg lycopene as Lyc-O-Mato capsule daily | Serum MDA (μM):The mean reduction of serum MDA was 10% for all interventionsSerum thiols (μM):Mean 23.6% decrease in thiols for all treatment groupsSufficient outcome data not reported |
Misra et al., 2006 (33); New Delhi, India | II/ɸ | Randomized controlled trial | 6 mo | n = 41 Postmenopausal women; Aged <60 y, cessation of menses >1 y ago, or >6 mo; FSH level >40 u/L; NonsmokerHRT group: n = 21; Age: 46.2 y; BMI: 25.3 kg/m2LycoRed group: n = 22; Age: 46.4 y; BMI: 25.8 kg/m2No statistically significant differences between groups | Group 1: Oral HRT dailyGroup 2: 2 x LycoRed softules (containing 2000 μg lycopene each) daily | MDA (μmol/L):Baseline: 38.3 ± 6.3; 3 Mo: 34.7 ± 4.0; 6 Mo: 34.0 ± 3.7P-value: 0.001*GSH (μmol/L):Baseline: 7.5 ± 1.2; 3 Mo: 9.0 ± 1.3; 6 Mo: 9.8 ± 1.9P-value: 0.001*Significant difference in mean levels between the 2 groups at 0 and 6 moResults reported are for LycoRed group.[Mean (SD)] |
Collins et al., 2004 (14); Beltsville, MD, USA | III-2/- | Diet-controlled, repeated measures, cross-over controlled trial | 19 wk (2-wk wash-out, 3-wk intervention, 4-wk wash-out, repeated for each intervention) | n = 10; 5 Males; Healthy, nonsmokers; Mean age: 50 y; Mean BMI: 27.7 kg/m2 | Watermelon juice: 20.1 mg lycopene/d from watermelon juiceTomato juice: 18.4 mg lycopene per day from tomato juiceControl: no added lycopene | MDA (μmol/L):Depletion: 1.21 ± 0.11Postintervention: Control: 1.12 ± 0.11; Watermelon: 1.15 ± 0.12; Tomato: 1.37 ± 0.11FRAP (μmol/L):Depletion: 831.6 ± 24.9Postintervention: Control: 871.7 ± 26.7; Watermelon: 900.9 ± 25.2; Tomato: 861.6 ± 23.4GPX (μmol/L):Depletion: 2728 ± 219Postintervention: Control: 2728 ± 222; Watermelon: 2263 ± 169; Tomato: 2574 ± 187 Results reported on group 1[Mean ± SE] |
Ghavipour et al., 2015 (12); Tehran, Iran | II/ɸ | Randomized controlled clinical trial | 20 d | n = 64; Overweight or obese female students; Aged between 20 and 30 y; BMI >25 kg/m2; Nonsmoker; no inflammatory diseasesIntervention group: n = 32; Age: 25.2 ± 0.6 y; BMI: 29.4 ±0.23 kg/m2Control group: n = 32; Age: 25.4 ± 0.7 y; BMI: 29.1 ± 0.30 kg/m2 [mean ± SEM] | Intervention group: 330 mL (37.0 mg lycopene) tomato juice dailyControl: Water | TAC (mg/dL):Baseline: Intervention: 0.4 ± 0.4, Control: −0.2 ± 0.4P-value: 0.03SOD (U/gHb):Baseline: Intervention: 27.4 ± 10.2, Control: 1.9 ± 1.1P-value: 0.01*GPx (U/gHb):Baseline: Intervention: 28.4 ± 2.5, Control: 2.0 ± 0.0P-value: 0.01*CAT(U/gHb):Baseline: Intervention: 4.9 ± 0.0, Control: 0.92 ± 0.77P-value: 0.02*MDA (μmol/mL):Baseline: Intervention: -0.4 ± 0.8, Control: 0.3 ± 0.6P value: 0.01 ANCOVA, adjusted for age, BMI, and daily energy intake[Mean ± SEM] |
Colmán Martínez et al., 2017 (41); Valencia, Spain | II/ɸ | Open, prospective, randomized, cross-over and | 18 wk (4-wk intervention, 3-wk wash-out) | n = 28; High cardiovascular risk; Mean age: 69.7 ± 3.1 y; Mean BMI: 31.5 ± 3.6 kg/m2 | Low dose: 200 mL Tomato juice dailyHigh dose: 400 mL Tomato | ICAM-1 (ng/mL):Control: 3624 ± 773; Postintervention: 156 ± 688 |
controlled clinical trial | juice dailyControl: Water | P ≤ 0.001VCAM-1 (ng/mL):Control: 3945 ± 561; Postintervention: 213 ± 540P ≤ 0.001IL-8 (pg/mL):Control: 40 ± 90; Postintervention: 24 ± 79P-value: 0.135IFN-ɣ (pg/mL):Control: 450 ± 307; Postintervention: 399 ± 265P- value: 0.791[Mean ± SD] Results are for high-dose intervention | ||||
Carroll et al., 2000 (42); Cork, Ireland | II+ | Randomized, placebo-controlled double-blind study | 12 wk | n = 51; Healthy elderly people over 65 y; nonsmoking; 22 males, 25 femalesLycopene group: n = 16; Age: 70 ± 5 y; BMI: 26.0 ± 3 kg/m2; Total-C: 5.7 ± 0.8 mmol/L; HDL-C: 1.2 ± 0.3 mmol/L; TGs: 1.2 ± 0.5 mmol/L [mean ± SD] | Lycopene: One Lyc-O-Pen capsule per day (13.3 mg lycopene/d)Carotene: One carotene capsule per day (8.2 mg B-carotene)Placebo capsule | Maximal oxidation rate (nmol/mg) LDL-C protein/min):Placebo: Baseline: 8.61 ± 2.94; 12 wk: 8.73 ± 3.03Lycopene: Baseline: 8.69 ± 2.51; 12 wk: 8.47 ± 1.56Lag Phase (min):Placebo: Baseline: 57 ± 21; 12 wk: 56 ± 11Lycopene: Baseline: 54 ± 20; 12 wk: 62 ± 22Maximum diene concentration (nmol/mg LDL-C protein):Placebo: Baseline: 705 ± 153; 12 wk: 701 ± 169Lycopene: Baseline: 696 ± 142; 12 wk: 679 ± 99[Mean ± SD] |
Sarkar et al., 2012 (43); Indore, India | III-2/ɸ | Case-control intervention study | 60 d | n = 60; Aged 40–60 y, nonsmokersStudy subjects: n = 30; Oxidative stress; No history of chronic illnessControl subjects: n = 30; Healthy and without illness or oxidative stress | 180 g tomato (e.g., soups, paste, ketchup) containing 12 mg lycopene/d | MDA (nmol/mL):Baseline: 6.5 ± 0.7; Postintervention: 3.73 ± 0.7*SOD (units/mL)Baseline: 3.2 ± 0.7; Postintervention: 5.9 ± 0.7*GPX *(unit/gHb):Baseline: 48.3 ± 5.4; Postintervention: 73.4 ± 7.6*GSH (unit/gHb):Baseline: 8.1 ± 1.1; Postintervention: 9.3 ± 0.1 Statistically significant, P-value < 0.05[Mean ± SD] |
Xaplanteris et al., 2012 (44); Athens, Greece | III-1/+ | Randomized, single-blinded, cross-over trial | 8 wk | n = 19; Healthy volunteers; 8 males | Supplementation: 70 g tomato paste/d (33.3 mg lycopene/d)Control: No tomato products | FMD (%):Tomato supplement: Baseline: 4.2 ± 5.1; Day 1: 5.6 ± 3.6; Day 15: 7.5 ± 3.5 Control: Baseline: 5.0 ± 3.5; Day 1: 4.7 ± 3.5; Day 15: 4.5 ± 3.5P-value: 0.047NMD (%)LTomato supplement: Baseline: 15.5 ± 6.1; Day 1: 16.2 ± 6.1; Day 15: 14.6 ± 6.1Control: Baseline: 13.6 ± 10.0; Day 1: 15.2 ± 10.5; Day 15: 12.6 ± 8.3P -value: 0.358Baseline diameter (mm):Tomato supplement: Baseline: 2.94 ± 0.61; Day 1: 2.95 ± 0.61; Day 15: 2.93 ± 0.83Control: Baseline: 2.99 ± 0.57; Day 1: 2.93 ± 0.57; Day 15: 2.99 ± 0.52P-value: 0.592[Mean ± SD] P < 0.05 vs. first day for paired samples t test comparison between 2 time points |
Steinberg and Chait, 1998 (45); Seattle, WA, USA | II/ɸ | Randomized placebo-controlled trial | 8 wk (4-wk wash-out, 4-wk intervention) | n = 39; No marker of hyperlipidemiaControl group: n = 19 (12 women, 7 men); Age: 26.8 ± 2.2 y; BMI: 23.4 ± 0.8 kg/m2Test group: n = 20 (12 women, 8 men); Age: 29.8 ± 2.6 y; BMI: 26.5 ± 1.1 kg/m2 [mean±SD] | Intervention: 237mL tomato juice, supplemented with 600 mg ascorbic acid, 30 mg B-carotene, 400 mg all-rac-a-tocopherol/dPlacebo: 237 mL Nonsupplemented tomato juice per day | LDL-C oxidation:Sufficient outcome data not reported |
Hininger et al., 2001 (46); Tronche, France | II/- | Randomized controlled trial | 12 wk | n = 175; Healthy adult males with a stable lifestyle; nonsmokers; Serum retinol >1 μmol/L; BMI <28 kg/m2; Age: 25–45 y | Four groups receiving 15 mg/d vi. capsule of either:- Lycopene- β-carotene- Lutein- Placebo | GSH (μmol/L):Lycopene group: Week 0: 1022 ± 29; Week 12: 877 ± 32Placebo group: Week 0: 955 ± 29; Week 12: 857 ± 29GSSG (μmol/L):Lycopene group: Week 0: 29.1 ± 1.7; Week 12: 28.5 ± 1.9Placebo group: Week 0: 28.9 ± 2.1; Week 12: 27.7 ± 2.6SH groups (μmol/g proteins):Lycopene group: Week 0: 6.54 ± 0.10; Week 12: 6.06 ± 0.05Placebo group: Week 0: 6.32 ± 0.16; Week 12: 6.03 ± 0.07[Mean ± SEM] |
Riso et al., 2006 (42); Milan, Italy | III-2/ɸ | Double-blind, placebo-controlled, cross-over trial | 78 d (∼11 wk) | n = 26; Healthy; no history of chronic illnessGroup 1: n = 13; age: 25.7 ± 2.1 y; BMI: 21.2 ± 2.2 kg/m2Study sequence: Placebo/wash-out/Lyc-O-MatoGroup 2: n = 13; Age: 25.9 ± 3.4 y; BMI: 20.9 ± 1.9 kg/m2 [mean ± SD]Study sequence: Lyc-o-Mato/wash-out/placebo | Lyc-O-Mato: 1 bottle (250 mL) of Lyc-O-Mato (5.7 mg lycopene/d)Placebo: 1 bottle (250 mL) of placebo drink/d | IFN-y (ng/mL):Placebo: Pre-placebo: 9.3 (6.2); Post-placebo: 21.3 (15.7)Supplement: 34.4% reduction from before intervention to after8-iso-PGF2a (ng/mL):Placebo: Pre: 2.4 (0.2), Post: 2.1 (0.2)Supplement: Pre: 2.3(0.2), Post: 2.4(0.2)Endogenous lymphocyte DNA damage—DNA in tail:Placebo: Pre: 2.6 ± 1.3, Post: 2.6 ± 1.1Supplement: Pre: 3.3 ± 1.9, Post: 2.8 ± 1.2[Mean ± SD] or [median (range)] |
Upritchard et al., 2000 (46); Dunedin, New Zealand | II/ɸ | Randomized placebo-controlled parallel trial | 8 wk (4-wk placebo, 4-wk intervention) | n = 57; T2D; <75 y; nonsmoker; HbA1c level <10%; Fasting plasma glucose level <11 mmol/L;Tomato juice: n = 15; Age: 63±8 y; M/F: 10/5; Duration of diabetes: 4.9 ± 5.5 y; BMI: 30.9±7.0 kg/m2Vitamin E: n = 12; Age: 56 ± 9 y; M/F: 6/6; Duration of diabetes: 5.8 ± 7.6 y; BMI: 31.5 ± 7.4 kg/m2Vitamin C: n = 12; Age: 56 ± 9 y; M/F: 6/6; Duration of diabetes: 1.9 ± 1.3 y; BMI: 30.7 ± 6.3 kg/m2Placebo: n = 13; Age: 60 ± 6 y; M/F: 10/3; Duration of diabetes: 3.2 ± 2.4 y; BMI: 31.8 ± 2.4 kg/m2 [mean ± SD] | 800 IU/d, vitamin E500 mg/d, vitamin C250 mL tomato juice twice a dayPlacebo capsule | Lag time (min):Tomato juice: Baseline: 69 ± 18; End of run-in: 71 ± 24; Postintervention: 101 ± 27*Placebo:Baseline: 81 ± 21: End of run-in: 86 ± 23; Postintervention: 80 ± 23[Mean ± SD] or [median (range)]*Statistically significant from baseline, P < 0.05 |
Briviba et al., 2004 (47); Karlsruhe, Germany | III-1/- | Randomized, cross-over trial | 10 wk (2 × 2-wk intervention, 3 × 2-wk wash-out period) | n = 22 Healthy men; Nonsmokers | 330 mL/d tomato juice (37 mg/lycopene)330 mL/d carrot juice (27 mg/β-carotene) | LDL-C oxidation lag time (min):Increased by 4.5% for both groups after 2-wk interventionP-value: 0.08Plasma MDA (μmol/L):Tomato juice: Before: 0.46 ± 0.17; After: 0.43 ± 0.16; 2 wk after: 0.42 ± 0.15Carrot juice: Before: 0.43 ± 0.17; After: 0.43 ± 0.20; 2 wk after: 0.42 ± 0.17[Mean ± SD]*P-value considered significant from baseline at <0.05 |
MacKinnon et al., 2011 (45); Toronto, Canada | II/+ | Randomized, placebo-controlled intervention study | 5 mo (1-mo wash-out, 4-mo intervention) | n = 60 Females; >1-y postmenopausal; nonsmokers; aged 50–60 y | Twice daily of either: 1) 15 mg lycopene from tomato juice; 2) 35 mg lycopene from lycopene-rich tomato juice; 3) 15 mg lycopene from Lyc-O-Mato capsules; 4) Placebo (0 mg lycopene/d) | Protein thiols (μM):15.56 ± 3.75% increase from baseline in lycopene supplemented group; P < 0.0015.09 ± 3.19% decrease from baseline in placebo group; P < 0.005TBARS (nmol/mL):Lycopene supplement group: Baseline: 7.91 ± 0.46; Postintervention: 6.80 ± 0.35P < 0.00111.93 ± 2.16% significant decrease |
Sarkar et al., 2012 (48); Madhya, Pradesh | II/- | Randomized controlled trial | 12 wk (2-wk lycopene-restricted diet, 10-wk intervention) | n = 75Patient group: n = 45; Had oxidative stress; Age: 52.4 ± 4.8 y, 25/20 (M/F)Control group: n = 30; Controls with sedentary lifestyle doing yoga regularly; Age: 50.4 ± 5.7 y; 16/14 (M/F) [mean ± SD] | Group 1: 1 capsule (15 mg lycopene)Group 2: 200 mg of tomato products (soup, paste, ketchup) with 15 mg lycopeneGroup 3: Placebo capsule | GPX (unit/gHb)MDA (nmol/mL)SOD (units/mL)Sufficient outcome data not reported |
Agarwal and Rao, 1998 (49); Toronto, Canada | III-1/- | Randomized, cross-over trial | 8 wk (1-wk intervention, 1-wk wash-out, repeated for each intervention) | n = 19; 10 Males; Nonsmoker; Aged 25–40 y (mean 29 y); Mean weight: 67.6 ± 11.6 kg; Mean BMI: 24.0 ± 2.8 kg/m2 [mean ± SD] | Group 1: 126 g spaghetti sauce (39.2 mg lycopene)Group 2: 540 mL tomato juice (50.4 mg lycopene)Group 3: 1.243 g of 6% lycopene oleoresin from tomatoes (75.0 mg lycopene)PlaceboDaily | LDL-C oxidation (mmol/mol LDL-C): All dietary lycopene treatments significantly lowered serum LDL oxidation over the placeboLDL-TBARS (mmol/mol LDL): Mean decrease over placebo was 25%LDL-CD (mmol/mol LDL): Mean decrease over placebo was 13% |
Porrini et al., 2002 (40); Milan, Italy | III-1/- | Controlled cross-over intervention Study | 8 wk (3-wk intervention 1, 2-w wash-out, 3-wk intervention 2) | n = 9 Healthy females; Nonsmoking; Age: 25.2 ± 2.2 y; BMI: 20.2 ± 1.6 kg/m2 | Intervention 1: 150 g spinach + 10g olive oil daily Intervention 2: 150 g spinach + 25g tomato puree (7 mg lycopene/d) + 10g olive oil | Lymphocyte oxidative damage: % DNA in tailSufficient outcome data not reported |
Samaras et al., 2014 (47); Larissa, Greece | III-2/+ | Parallel-controlled trial (randomization unclear) | 8 wk | n = 27 Ultra-marathon runners; nonsmokers; no medical history of HTTomato juice: 13 Males, 2 Females; Age: 44.9 ± 8.53 y; BMI: 24.1 ± 2.46 kg/m2Control: 12 Males; Age: 46.6 ± 15.3 y; BMI: 24.3 ± 1.56 kg/m2 [mean ± SD] | Tomato juiceDose: Amount required to match subjects with usual carbohydrate supplementation (unspecified amount) | FMDBaseline: 20.2 ± 9.9; FMDSupplement: 25.7 ± 10.2P- value: 0.028*GSHBaseline (μmol/L): 35.4 ± 15.8; GSHSupplement (μmol/L): 34.9 ± 6.08P-value: 0.902 TBARSBaseline (μmol/L): 7.11 ± 1.44; TBARSSupplement (μmol/L): 4.94 ± 12.6P-value: 0.001*TACBaseline (mmol DPPH/L): 0.961 ± 0.126; TACSupplement (mmol DPPH/L): 1.020 ± 0.092P-value: 0.065 All values reported on intervention group[Mean ± SD] |
Blum et al., 2007 (44); Haifa, Israel | III-2/ɸ | Parallel-controlled trial | 4 wk | n = 103; Healthy overweightIntervention group: n = 50; 33 Women; Age: 45.5 ± 14 y; BMI: 28.1 ± 3.155 kg/m2 Control group: n = 53; 35 Women; Age: 45.1 ± 13.5 y; BMI: 30.5 ± 1.51 kg/m2 [mean ± SD] | Regular diet supplemented with tomatoDose: 300 g tomato products (including TS, TJ, FT, tomato soup) per day | ICAM-1: Baseline: 286.47 ± 80.80; Postintervention: 307.44 ± 89.80P-value: 0.07E-selectin: Baseline: 55.37 ± 34.35; Postintervention: 61.20 ± 40.20P-value: 0.14 Results are for tomato-rich diet group[Mean ± SD] |
Inflammatory biomarkers | ||||||
Biddle et al., 2015 (50); Kentucky, USA | II/+ | 2-Group, randomized controlled intervention pilot study | 30 d | n = 40; Patients with HF; hospitalized for HF within the last 6 mo; >21 y; Males = 30.7 kg/m2, Females = 31.9 kg/m2Intervention group: n = 22; 8 Males, 10 females; Age: 65 ± 11 yControl group: n = 18; 15 Males, 7 females; Age: 65 ± 9 y | Regular diet supplemented with tomato juice Dose: 11.5 ounces of V8 tomato juice per day (29.4 mg lycopene/d) | CRP (mg/L)Interventionbaseline: 3.4 ± 3.1; InterventionPostintervention: 3.1 ± 2.8Controlbaseline: 4.8 ± 3.4; ControlPostintervention: 4.5 ± 3.8 P < 0.5 for time and group effect[Mean ± SD] |
Blum et al., 2007 (44); Haifa, Israel | III-2/ɸ | Parallel-controlled trial | 4 wk | n = 103 Healthy overweightIntervention group: n = 50; 33 Women; Age: 45.5 ± 14 y; BMI: 28.1 ± 3.155 kg/m2Control group: n = 53; 35 Women; Age: 45.1 ± 13.5 y; BMI: 30.5 ± 1.51 kg/m2 [mean ± SD] | Regular diet supplemented with tomatoDose: 300 g tomato products (including TS, TJ, FT, tomato soup) per day | hsCRP: Baseline: 0.43 ± 0.59; Postintervention: 0.41 ± 0.40P-value: 0.70 |
Upritchard et al., 2000 (46); Dunedin, New Zealand | II/ɸ | Randomized placebo-controlled parallel trial | 8 wk (4-wk placebo, 4-wk intervention) | n = 57; T2D; <75 y; nonsmoker; HbA1c level <10%; Fasting plasma glucose level <11 mmol/LTomato juice: n = 15; Age: 63 ± 8 y; M/F: 10/5; Duration of diabetes: 4.9 ± 5.5 y; BMI: 30.9±7.0 kg/m2Vitamin E: n = 12; Age: 56 ± 9 y; M/F: 6/6; Duration of diabetes: 5.8 ± 7.6 y; BMI: 31.5 ± 7.4 kg/m2Vitamin C: n = 12; Age: 56 ± 9 y; M/F: 6/6; Duration of diabetes: 1.9 ± 1.3 y; BMI: 30.7±6.3kg/m2Placebo: n = 13; Age: 60 ± 6 y; M/F: 10/3; Duration of diabetes: 3.2 ± 2.4 y; BMI: 31.8 ± 2.4 kg/m2 [mean ± SD] | 800 IU/d, vitamin E500 mg/d, vitamin C250 mL tomato juice twice a dayPlacebo capsule | CRP (mg/L):Tomato juice: Baseline:3.8 (0.5–17.4); End of run-in:3.5 (0.5–16.2); Postintervention:4.1 (1.2-14.6)Placebo: Baseline: 3.1 (0.5–19.5); End of run-in: 2.9 (1.0–10.6); Postintervention: 3.1 (0.6–12.3)[Mean ± SD] or [median (range)]Statistically significant from baseline, P < 0.05 |
Kim et al., 2011 (24); Seoul, Republic of Korea | II/+ | Randomized, double-blind, placebo-controlled intervention trial | 8 wk | n = 126; Healthy men; Age: 22–57 y; Frequently smoke cigarettes or consume alcohol; <3 servings vegetables and fruit per week; No history of chronic disease | Low dose: 6 mg lycopene/d via capsuleHigh dose: 15 mg lycopene/d via capsulePlacebo | hs-CRP (mg/dL):Placebo: Pretreatment: 1.14 ± 0.07; Post-treatment: 1.10 ± 0.27Low dose: Pretreatment: 1.39 ± 0.33; Post-treatment: 1.40 ± 0.37High dose: Pretreatment: 1.25 ± 0.44; Post-treatment: 0.54 ± 0.10*[Mean ± SE]*P < 0.05 compared with baseline values in each group tested by paired t test = P < 0.001 compared with baseline values in each group tested by paired t test |
Colmán Martínez et al., 2017 (51); Valencia, Spain | II/ɸ | Open, prospective, randomized, cross-over, and controlled clinical trial | 18 wk (4-wk intervention, 3-wk wash-out) | n = 28; High cardiovascular risk; Mean age: 69.7 ± 3.1 y; Mean BMI: 31.5 ± 3.6 kg/m2 | Low dose: 200 mL Tomato juice dailyHigh dose: 400 mL Tomato juice dailyControl: Water | CRP (ng/mL):Control: 546 ± 243; Postintervention: 530 ± 228P-value: 0.228[Mean ± SD] Results are for high-dose intervention |
Jacob et al., 2008 (52); Jena, Germany | II/- | Randomized intervention study | 4-wk (2-wk wash-out, 2-wk intervention) | n = 24 Healthy volunteers; Nonsmokers; Age: 23 ± 2 y; BMI: 21.5 ± 2.8 kg/m2 [mean ± SD] | Group L: 250 mL tomato juice twice daily (20.9 mg lycopene/d)Group LC: Same tomato juice enriched with vitamin C | CRP (μg/L):L: T-2: 336.2 ± 267.3; T0: 315.6 ± 257.7; T±2: 262.3 ± 215.4; LC: T–2: 349.5 ± 279.4; T0: 319.2 ± 212.5; T±2: 247.1 ± 179.3P- value: 0.792[Mean ± SD] |
Other measures | ||||||
Neyestani et al., 2007 (33); Tehran, Iran | III-1/ɸ | Placebo-controlled clinical trial | 10 wk (2-wk wash-out, 8-wk intervention) | n = 35 T2D patients; nonsmokers; Aged 35–70 y; 19 women, 16 men | Lycopene supplement (10 mg lycopene/d)Placebo capsule | IgM (mg/dL):Lycopene: Initial: 207.7 ± 35.7; Final: 227.2 ± 42.6Placebo: Initial: 219.4 ± 71.2; Final: 215.4 ± 57.7IgG (mg/dL):Initial: 1471.3 ± 572.8; Final: 1462.8 ± 572.9Placebo: Initial: 1422.3 ± 318.6; Final: 1251.8 ± 261.7slgA (mg/dL):Lycopene: Initial: 9.3 ± 3.8; Final: 10.0 ± 3.4Placebo: Initial: 9.4 ± 2.6; Final: 17.4 ± 32.9[Mean±SD]significant difference between initial and final |
Graydon et al., 2007 (31); Belfast, United Kingdom | II/ɸ | Randomized, double-blinded, placebo-controlled trial | 4 wk | n = 20 Healthy male volunteers; Aged 18–60 yearsLycopene group: n = 10; Age: 32 y (26, 41 y); 10% smokersPlacebo: n = 10; Age: 39 y (28, 48 y); 10% smokers [median (IQR)] | Dose: 15 mg lycopene capsule, once per dayPlacebo capsule | IGF-I (ng/mL):Lycopene: 0.29 (0.09, 0.46); Placebo: 0.03 (−0.11, 0.08)P-value: 0.52IGFBP-3 (ng/mL):Lycopene: 245 (−109, 484); Placebo: 101 (−34, 234)P value: 0.55[Median (IQR)] |
1BP, blood pressure; CRP, C-reactive protein; CVD, cardiovascular disease; DBP, diastolic blood pressure; DPPH, 2,2-diphenyl-1-picrylhydrazyl; HbA1c, glycated hemoglobin; HDL-C, HDL cholesterol; HPT, hypertensive; hsCRP, high-sensitivity C-reactive protein; HT, hypertension; Ig, immunoglobulin; IGF-I, insulin-like growth factor I; IGFBP3, IGF binding protein 3; LDL-C, LDL cholesterol; LSM, least-square means; MDA, malondialdehyde; MetS, metabolic syndrome; NHMRC, National Health and Medical Research Council; Quality Ax, Quality Assessment; SBP, systolic blood pressure; TAC, total active cannabinoids; TBARS, thiobarbituric acid reactive substances; TC, total cholesterol; TG, triglyceride; TJ, tomato Juice; TS, tomato sauce; T2D, type 2 diabetes; WC, waist circumference (cm).