Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index
PRIMARY OBJECTIVES:
I. To determine the effect of pharmacological doses of resveratrol on serum estradiol levels
in post-menopausal women with high body mass index (BMI).
SECONDARY OBJECTIVES:
I. Assess the effect of resveratrol on serum estrone, testosterone, and sex hormone-binding
globulin (SHBP).
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
lipid profile.
VII. Assess the relationship between systemic study agent exposure and biomarker modulation.
OUTLINE:
Patients receive resveratrol orally (PO) once daily (QD) for 12 weeks.
After completion of study therapy, patients are followed up for 2 weeks
Interventional
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
No
Hsiao-Hui (Sherry) Chow
Principal Investigator
University of Arizona Health Sciences Center
United States: Food and Drug Administration
NCI-2011-02593
NCT01370889
June 2011
Name | Location |
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University of Arizona Health Sciences Center | Tucson, Arizona 85724 |