Resveratrol in Postmenopausal Women With High Body Mass Index

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Healthy, no Evidence of Disease

Clinical Trial Details

NCT number	NCT01370889
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 1
Start date	June 2011
Completion date	July 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01950403` - Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers	Phase 1
Terminated	`NCT01336387` - Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers	Phase 1
Terminated	`NCT01561989` - Cholecalciferol and Flu Vaccine in Treating Healthy Participants	N/A
Completed	`NCT01140646` - Evaluation of SAMe for Hot Flashes	Phase 2
Completed	`NCT00892515` - Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer	N/A
Completed	`NCT00450957` - Lycopene in Healthy Male Participants	Phase 1
Completed	`NCT00365209` - Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)	Phase 2
Recruiting	`NCT04445532` - Hepatobiliary Tumors Tissue Samples Acquisition
Completed	`NCT02100254` - Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities	N/A
Completed	`NCT02129517` - Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials	N/A
Terminated	`NCT01755208` - Light-Scattering Spectroscopy for Detection of Breast Cancer	N/A
Completed	`NCT00499460` - Effects of Garlic Supplements on Opioids in Healthy Volunteers	Phase 4
Completed	`NCT00392652` - Diindolylmethane in Healthy Volunteers	Phase 1
Completed	`NCT01077453` - Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer	Phase 1
Completed	`NCT00478309` - Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants	N/A
Completed	`NCT00896207` - Studying Different Formulations of SR13668 in Healthy Volunteers	Phase 1
Completed	`NCT00679094` - Bowman-Birk Inhibitor Concentrate in Healthy Men	Phase 1
Terminated	`NCT02154984` - Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants	N/A
Completed	`NCT00489372` - Se-Methyl-Seleno-L- Cysteine (MSC) in Treating Healthy Patients	Phase 1
Completed	`NCT00513916` - Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women	Phase 3