Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index
I. To determine the effect of pharmacological doses of resveratrol on serum estradiol levels
in post-menopausal women with high body mass index (BMI).
I. Assess the effect of resveratrol on serum estrone, testosterone, and sex hormone-binding
II. Assess the effect of resveratrol on serum levels of insulin and C-peptide. III. Assess
the effect of resveratrol on adipocytokine expression and secretion as measured by serum
leptin and adiponectin.
IV. Assess the effect of resveratrol on inflammatory cytokines as measured by serum
C-reactive protein (CRP).
V. Assess the effect of resveratrol on oxidative stress as measured by urinary
8-isoprostaglandin F2 alpha (8-iso-PGF2 alpha) and 8-hydroxydeoxyguanosine (8OHdG).
VI. Assess the safety of resveratrol intervention as measured by reported adverse events,
complete blood count with differential (CBC/diff), comprehensive metabolic panel (CMP), and
VII. Assess the relationship between systemic study agent exposure and biomarker modulation.
Patients receive resveratrol orally (PO) once daily (QD) for 12 weeks.
After completion of study therapy, patients are followed up for 2 weeks
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Change in serum estradiol levels from baseline (BL) to post-intervention (PI) in postmenopausal women with high BMI
A two-sided paired t-test will be performed to determine whether the change is significant at a significance level of 5%.
From baseline to 6 months
Hsiao-Hui (Sherry) Chow
University of Arizona Health Sciences Center
United States: Food and Drug Administration
|University of Arizona Health Sciences Center||Tucson, Arizona 85724|