PMID- 25115686 OWN - NLM STAT- MEDLINE DCOM- 20150304 LR - 20211021 IS - 1479-5876 (Electronic) IS - 1479-5876 (Linking) VI - 12 DP - 2014 Aug 14 TI - A pilot clinical study of resveratrol in postmenopausal women with high body mass index: effects on systemic sex steroid hormones. PG - 223 LID - 10.1186/s12967-014-0223-0 [doi] LID - 223 AB - BACKGROUND: Breast cancer risk is partially determined by several hormone-related factors. Preclinical and clinical studies suggested that resveratrol may modulate these hormonal factors. METHODS: We conducted a pilot study in postmenopausal women with high body mass index (BMI >/= 25 kg/m2) to determine the clinical effect of resveratrol on systemic sex steroid hormones. Forty subjects initiated the resveratrol intervention (1 gm daily for 12 weeks) with six withdrawn early due to adverse events (AEs). Thirty-four subjects completed the intervention. RESULTS: Resveratrol intervention did not result in significant changes in serum concentrations of estradiol, estrone, and testosterone but led to an average of 10% increase in the concentrations of sex steroid hormone binding globulin (SHBG). Resveratrol intervention resulted in an average of 73% increase in urinary 2-hydroxyestrone (2-OHE1) levels leading to a favorable change in urinary 2-OHE1/16alpha-OHE1 ratio. One participant had asymptomatic Grade 4 elevation of liver enzymes at the end of study intervention. Two subjects had Grade 3 skin rashes. The remaining adverse events were Grade 1 or 2 events. The most common adverse events were diarrhea and increased total cholesterol, reported in 30% and 27.5% of the subjects, respectively. CONCLUSION: We conclude that among overweight and obese postmenopausal women, daily 1 gm dose of resveratrol has favorable effects on estrogen metabolism and SHBG. Further placebo-controlled studies are needed to confirm our findings on these hormone-related breast cancer risk factors and the attribution of the adverse effects observed in the study population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01370889. FAU - Chow, H-H Sherry AU - Chow HH AD - University of Arizona Cancer Center, 1515 N Campbell Ave, Tucson, 85724, AZ, USA. schow@azcc.arizona.edu. FAU - Garland, Linda L AU - Garland LL FAU - Heckman-Stoddard, Brandy M AU - Heckman-Stoddard BM FAU - Hsu, Chiu-Hsieh AU - Hsu CH FAU - Butler, Valerie D AU - Butler VD FAU - Cordova, Catherine A AU - Cordova CA FAU - Chew, Wade M AU - Chew WM FAU - Cornelison, Terri L AU - Cornelison TL LA - eng SI - ClinicalTrials.gov/NCT01370889 GR - N01CN35158/CA/NCI NIH HHS/United States GR - P30 CA023074/CA/NCI NIH HHS/United States GR - CA023074/CA/NCI NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20140814 PL - England TA - J Transl Med JT - Journal of translational medicine JID - 101190741 RN - 0 (Estrogens) RN - 0 (Gonadal Steroid Hormones) RN - 0 (Stilbenes) RN - Q369O8926L (Resveratrol) SB - IM MH - Adult MH - *Body Mass Index MH - Demography MH - Estrogens/blood MH - Female MH - Gonadal Steroid Hormones/*blood MH - Humans MH - Middle Aged MH - Pilot Projects MH - Postmenopause/blood/*drug effects MH - Resveratrol MH - Stilbenes/adverse effects/blood/*pharmacology PMC - PMC4243716 EDAT- 2014/08/15 06:00 MHDA- 2015/03/05 06:00 PMCR- 2014/08/14 CRDT- 2014/08/14 06:00 PHST- 2014/04/17 00:00 [received] PHST- 2014/08/01 00:00 [accepted] PHST- 2014/08/14 06:00 [entrez] PHST- 2014/08/15 06:00 [pubmed] PHST- 2015/03/05 06:00 [medline] PHST- 2014/08/14 00:00 [pmc-release] AID - s12967-014-0223-0 [pii] AID - 223 [pii] AID - 10.1186/s12967-014-0223-0 [doi] PST - epublish SO - J Transl Med. 2014 Aug 14;12:223. doi: 10.1186/s12967-014-0223-0.