Table 4.
Characteristics and findings of publications associated with the registered trials on extracts or pure compounds.
| Reference, country, registry ID | Study design | Study population | Duration of intervention | Food or supplement intervention | Control or placebo intervention | Primary outcome and other variable outcomes | Main findings |
|---|---|---|---|---|---|---|---|
| Poulton et al. (50), USA, NCT00621309 | Randomized, crossover, controlled | n = 23 healthy non-smoker subjects (11F, 12M) age 23.7 y (20–37 y), BMI 23.4 ± 2.7 kg/m2 | 7 days | Group 1: 450 μmol SFN (BSE) + cheese soup dailyGroup 2: 450 μmol SFN (BSE) + cheese soup and 300 mg rifampicin daily | Group 3: cheese soup and 300 mg rifampicin daily | Pharmacokinetic Measure of Cytochrome P450 3A4 Activity (primary outcome) | ↔ |
| Haber et al. (51), USA, NCT00882115 | Non controlled, baseline and post-intervention | n = 28 healthy subjects (14F, 14M) | 4 days | 1.25 g BSE (100 μmol SFN) | NA | Total number of nasal leukocytes (primary outcome) | ↓ |
| Singh et al. (52), USA, NCT01474993 | Randomized, parallel, placebo-controlled, quadruple-blind |
n = 40 males patients with ASD, age 13–27 y SFN treated group: n = 26 Placebo group: n = 14 |
18 weeks | SFN-rich BSE: 50 μmol SFN for weight <100 lb 100 μmol SFN for weight = 101–199 lb 150 μmol SFN for weight > 200 lb |
Microcrystalline cellulose | SRS (primary outcome), ABCS CGI-I |
↓ ↑ |
| Atwell et al. (53), USA, NCT00843167 | Randomized, parallel, placebo-controlled, triple-blind | n = 54 females with diagnostic mammogram, age 54 ± 12 y, BMI 27.3 ± 5.6 kg/m2 | 2–8 weeks | ~250 mg broccoli seed extract, 2 pills 3 ×/day (224 mg GR total daily dose) | Microcrystalline cellulose 3 × /day | Urinary levels of ITCs (primary outcome) HDA Activity (primary outcome) Ki-67 (primary outcome), HDAC3 H3K9ac p21, HDAC6, H3K18ac |
↑ ↓ ↓ in benign tissues in the SFN group ↓ in ductal carcinoma tissue in the placebo group ↔ |
| Rajendran et al. (54), USA, NCT01543074 | Randomized, parallel, placebo-controlled, double-blind |
n = 10 healthy subjects BSE group: n = 5 Placebo group: n = 5 |
7 days | 200 μmol SFN equivalent of BSE | Placebo | Blood levels of SFN and its metabolites | ↑ |
| Shiina et al. (55), Japan, NCT01716858 | Non controlled, baseline and post-intervention | n = 10 patients with schizophrenia (6F, 4M) age 42.7 ± 11 y | 8 weeks | 30 mg SFN-GSL daily | NA | PNSS (primary outcome), Levels of brain-derived neurotrophic factors CogState |
↔ ↑ only in the Accuracy component of the One Card Learning Task |
| Yuan et al. (56), USA, NCT00691132 | Randomized, crossover, placebo-controlled, double-blind | n = 82 healthy current smokers (38F, 44M) age 41 ± 10.1 y, BMI 28 ± 5.6 kg/m2 | 5 weeks | 10 mg of PEITC in 1 ml olive oil, 4 times/day, once every 4 h for 5 days | Olive oil, 4 times/day, once every 4 h for 5 days | Urinary levels of total ITCs and PEITC-NAC (primary outcome) The ratio of urinary [pyridine-D4]hydroxy acid: total [pyridine-D4]NNAL (primary outcome), urinary levels of PEITC-NAC and total ITCs by GSTM1 or both genotypes GSTM1 and GSTT1 Urinary levels of PEITC-NAC and total ITCs by GSTT1 genotypes |
↑ ↓ ↔ |
| Wise et al. (57), USA, NCT01335971 | Randomized, 3-arm parallel, placebo-controlled, quadruple-blind |
n = 89 smoker with physician diagnosed COPD subjects Placebo group: n = 31 (15F, 16M) age 59 (52–67) Group 1: n = 29 (12F, 17M) age 59 (54–65) y Group 2: n = 29 (8F, 21M) age 56 (52–62) y |
1 month | Group 1: 25 μmol SFN daily Group 2: 150 μmol SFN daily |
Microcrystalline cellulose | Alveolar macrophage expression of Nrf2, NQ01, HO1, AKR1C1, AKR1C3 (primary outcome), bronchial epithelial cell expression of Nrf2, NQ01, HO1, AKR1C1, AKR1C3 (primary outcome), isoprostane, TBARS in plasma and expired breath condensate, cytokine profiles in bronchoalveolar lavage fluid |
↔ |
| Axelsson et al. (58), Sweden, NCT02801448 | Randomized, parallel, placebo-controlled, quadruple-blind | n = 97 patients with type 2 diabetes (24F, 73M) age 35–75 y, BMI 30.4 ± 4.0 kg/m2 | 12 weeks | 150 μmol SFN in BSE daily | Maltodextrin sprayed with copper chlorophyllin | HbA1c (primary outcome) Fasting blood glucose BMI, Fatty liver index, liver parameters, TC, TG, Hb |
↓ ↓ in obese dysregulated T2D patients ↔ |
| Bent et al. (59), USA, NCT02654743 | Non controlled, baseline and post-intervention | n = 15 child with ASD (3F, 12M) age 14.7 y | 12 weeks | 1 μmol SFN/2.2 kg body weight daily with tablets, each one containing 125 mg BSE, 50 mg dried broccoli sprouts, 15 mg ascorbic acid and microcrystalline cellulose | NA | ABCS SRS |
↑ ↑ |
| Liu et al. (60), USA, NCT02561481 | Non controlled, baseline and post-intervention | n = 10 young males with ASD, age 9.9 y | 14 days | 12.5–15 mg GR (2.2 μmol SFN/kg body weight) and active plant-derived myrosinase daily | NA | NQO1, AKR1C1, HO-1, HSP70, HSP27 IL-6, IL-1β, TNF-α, Cox-2 |
↔ ↓ |
| Zhang et al. (61), USA, NCT01265953 | Randomized, parallel, placebo-controlled, triple-blind | n = 98 males at risk for prostate cancerPlacebo group: n = 48, age 64.9 ± 5 y, BMI 31.1 kg/m2BSE group: n = 50, age 65.7 y, BMI 28.9 kg/m2 | 4–8 weeks | 2 of BSE capsules daily (200 μmol SFN) | Gelatin capsule with microcrystalline cellulose | Total urine SFN metabolites (primary outcome), Total plasma SFN metabolites (primary outcome) PBMC HDAC activity levels Tissue levels of H3K18ac, HDAC3, HDAC6 (primary outcome), Ki-67(primary outcome), p21 ARLNC1 and AMACR gene expression |
↑ ↑ in subjects with prostate cancer ↔ ↓in prostate cancer tissue |
ABCS, Aberrant Behavior Checklist scale; AKR1C1, aldo-keto reductase Family 1 Member C1; AKR1C3, aldo-keto reductase Family 1 Member C3; AMACR, alpha-methylacyl-CoA racemase; ARLNC1, androgen receptor-regulated long noncoding RNA; ASD, Autism Spectrum Disorder; BMI, body mass index; BSE, broccoli sprouts extract; CGI-I, Clinical Global Impression Improvement Scale; COPD, chronic obstructive pulmonary disease; Cox2, cyclooxygenase-2; GR, glucoraphanin; GSTM1, glutathione S-transferase Mu 1; GSTT1, glutathione S-transferase theta-1; H3K18ac, acetylated histone H3 lysine 18; H3K9ac, acetylated histone H3 lysine 9; Hb, hemoglobin; HbA1c, glycated hemoglobin; HDAC, histone deacetylase; HDAC3, histone deacetylase 3; HDAC6, histone deacetylase 6; HO-1, heme oxygenase-1; HSP27, heat shock protein 70; HSP70, heat shock protein 70; IL-1β, Interleukin-1β; IL-6, Interleukin-6; ITCs, isothiocyanates; NA, not available; NQ01, NADPH quinone oxidoreductase-1; Nrf2, nuclear factor erythroid-2 related factor 2; PBMC, peripheral blood mononuclear cell; PEITC, 2-phenethyl isothiocyanate; PEITC-NAC, N-acetyl-S-(N-2-phenethylthiocarbamoyl)-L-cysteine; PNSS, Positive and Negative Syndrome Scale; SFN, sulforaphane; SRS, Social Responsiveness Scale; T2D, type 2 diabetes; TBARS, thiobarbituric acid reactive substances; TC, total cholesterol; TG, tryglicerides; TNF-α, Tumor Necrosis Factor-α; ↓, significant decrease; ↑, significant increase; ↔, no significant effect.