NCT01370889

Resveratrol in Postmenopausal Women With High Body Mass Index

Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

This pilot phase I trial studies resveratrol in postmenopausal women with high body mass index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of resveratrol may keep cancer from forming. Studying samples of blood and urine in the laboratory from postmenopausal women who are taking resveratrol may help doctors learn more about the effects of resveratrol on biomarkers.

Detailed description

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

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DRUG	resveratrol	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-06-10
• Last updated: 2014-10-09

Locations

2 sites across 1 country: United States