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. 2020 Jul 11;11(6):1453–1488. doi: 10.1093/advances/nmaa069

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).