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

Phase 1
35 Years
Open (Enrolling)
Healthy, no Evidence of Disease

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Trial Information

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


I. To determine the effect of pharmacological doses of resveratrol on serum estradiol levels
in post-menopausal women with high body mass index (BMI).


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.


Patients receive resveratrol orally (PO) once daily (QD) for 12 weeks.

After completion of study therapy, patients are followed up for 2 weeks

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Change in serum estradiol levels from baseline (BL) to post-intervention (PI) in postmenopausal women with high BMI

Outcome Description:

A two-sided paired t-test will be performed to determine whether the change is significant at a significance level of 5%.

Outcome Time Frame:

From baseline to 6 months

Safety Issue:


Principal Investigator

Hsiao-Hui (Sherry) Chow

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona Health Sciences Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease



University of Arizona Health Sciences Center Tucson, Arizona  85724