Resveratrol in Postmenopausal Women With High Body Mass Index

NCT01370889 | Completed Phase 1

• 6 other identifiers: NCI-2011-02593CDR000070140510-0653-04UAZ08-12-01P30CA023074N01CN35158
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• Change in serum estradiol levels 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%. If the data distribution indicates non-normality or skewedness in violation of the assumptions of the t-test, non-parametric tests will be used. Linear regression techniques will be used to adjust for potential confounders, e.g. age and BMI.

  From baseline to 12 weeks (post-intervention)

Secondary Outcomes (13)

• Change in serum estrone

  From baseline to 12 weeks (post-intervention)

• Change in serum testosterone

  From baseline to 12 weeks (post-intervention)

• Change in serum sex hormone-binding globulin (SHBG)

  From baseline to 12 weeks (post-intervention)

• Change in serum levels of insulin

  From baseline to 12 weeks (post-intervention)

• Change in serum levels of C-peptide

  From baseline to 12 weeks (post-intervention)

Study Arms (1)

Basic Science (resveratrol)

EXPERIMENTAL

Patients receive resveratrol PO QD for 12 weeks.

Drug: resveratrol; Other: laboratory biomarker analysis

Interventions

resveratrol DRUG

Given PO

Basic Science (resveratrol)

laboratory biomarker analysis OTHER

Correlative studies

Basic Science (resveratrol)

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal women with a body mass index (BMI) of 25 kg/m\^2 or greater
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Karnofsky 70% or above
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count (ANC) \>= 1,500/uL
• Platelets \>= 100,000/uL
• Total bilirubin =\< 2.0 mg/dL
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 1.5 times upper limit of normal (ULN)
• Creatinine =\< 1.0 times ULN
• Ability and willingness to limit resveratrol-containing foods to no more than one serving each per day for about 14 weeks
• Negative mammogram or negative workup of mammographic findings within prior 12 months prior to enrollment for women \>= 50 years of age
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Have had invasive cancer(s) within the past 5 years except non-melanoma skin cancer
• Within 3 months of or concurrent usage of any other investigational agents
• History of allergic reactions attributed to resveratrol
• Unwilling or unable to refrain from taking herbal medicines and dietary supplements
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Within 3 months of or concurrent estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens; vaginal estrogen is acceptable.
• Within 3 months of or concurrent usage of tamoxifen, raloxifene, other selective estrogen-receptor modulators, or aromatase inhibitors
• Regular usage (more than 2 times a week) of estrogenic supplements or herbal remedies (e.g., Remifemin, black cohosh, red clover, dong quai, soy isoflavones, dehydroepiandrosterone \[DHEA\], flaxseed, diindolylmethane \[DIM\], genistein, and daidzein) within the past 3 months or concurrently; dietary consumption of phytoestrogens/isoflavones (such as soy, tofu, millet, barley, natto, tempeh, miso, soy milk, soy sauce) is acceptable as these sources are not concentrated
• Concurrent use of anti-diabetic drugs such as:
• Insulin
• Sulfonylureas (e.g., glipizide, glyburide, or glimepiride)
• Meglitinides (e.g., repaglinide or nateglinide)
• Biguanides (e.g., metformin)
• Thiazolidinediones (e.g., rosiglitazone or pioglitazone)
• Alpha-glucosidase inhibitors (e.g., acarbose or miglitol)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Arizona Cancer Center - Tucson

Tucson, Arizona, 85724-5024, United States

Location

University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Chow HH, Garland LL, Heckman-Stoddard BM, Hsu CH, Butler VD, Cordova CA, Chew WM, Cornelison TL. A pilot clinical study of resveratrol in postmenopausal women with high body mass index: effects on systemic sex steroid hormones. J Transl Med. 2014 Aug 14;12:223. doi: 10.1186/s12967-014-0223-0.

  PMID: 25115686 DERIVED

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Hsiao-Hui (Sherry) Chow

  University of Arizona Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 10, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 9, 2014

Record last verified: 2014-04

Locations

US (2)