Resveratrol in Postmenopausal Women With High Body Mass Index

NCT ID: NCT01370889

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-07-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Basic Science (resveratrol)

Patients receive resveratrol PO QD for 12 weeks.

Group Type: EXPERIMENTAL

resveratrol

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

resveratrol

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin)
• Concurrent use of warfarin or phenytoin

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiao-Hui (Sherry) Chow

Role: PRINCIPAL_INVESTIGATOR

University of Arizona Health Sciences Center

Locations

Arizona Cancer Center - Tucson

Tucson, Arizona, United States

University of Arizona Health Sciences Center

Tucson, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25115686 (View on PubMed)

Other Identifiers

NCI-2011-02593

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000701405

Identifier Type: -

Identifier Source: secondary_id

10-0653-04

Identifier Type: OTHER

Identifier Source: secondary_id

UAZ08-12-01

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA023074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CN35158

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2011-02593

Identifier Type: -

Identifier Source: org_study_id

NCT02022332

Identifier Type: -

Identifier Source: nct_alias