Clinical trial NCT01370889: Resveratrol in Postmenopausal Women With High Body Mass Index
Official title: Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy, no Evidence of Disease
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2011-06-10
Enrollment: 46
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Change in serum estradiol levels in postmenopausal women with high BMI
timeFrame: From baseline to 12 weeks (post-intervention)
Secondary outcomes:
measure: Change in serum estrone
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in serum testosterone
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in serum sex hormone-binding globulin (SHBG)
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in serum levels of insulin
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in serum levels of C-peptide
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in serum leptin
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in serum adiponectin
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in inflammatory markers, measured by serum C-reactive protein
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in urinary 8-iso-PGF2alpha
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Change in urinary 8OHdG
timeFrame: From baseline to 12 weeks (post-intervention)
measure: Incidence of reported adverse events
timeFrame: Up to 12 weeks
measure: Incidence of changes in CBC/diff, blood chemistry, and lipids
timeFrame: Up to 12 weeks
measure: Study agent/metabolite levels
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center - Tucson
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Health Sciences Center
state: Arizona
Study officials:
affiliation: University of Arizona Health Sciences Center
name: Hsiao-Hui (Sherry) Chow
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.