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


Phase 1
35 Years
N/A
Open (Enrolling)
Female
Healthy, no Evidence of Disease

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Trial Information

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


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


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

Type of Study:

Interventional

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:

No

Principal Investigator

Hsiao-Hui (Sherry) Chow

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona Health Sciences Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02593

NCT ID:

NCT01370889

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease

Name

Location

University of Arizona Health Sciences CenterTucson, Arizona  85724