Resveratrol in Postmenopausal Women With High Body Mass Index

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01370889
First received: June 9, 2011
Last updated: August 12, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy, no Evidence of Disease
Drug: resveratrol
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in serum estradiol levels in postmenopausal women with high BMI [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in serum estrone [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in serum testosterone [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in serum sex hormone-binding globulin (SHBG) [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in serum levels of insulin [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in serum levels of C-peptide [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in serum leptin [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in serum adiponectin [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in inflammatory markers, measured by serum C-reactive protein [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in urinary 8-iso-PGF2alpha [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Change in urinary 8OHdG [ Time Frame: From baseline to 12 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.

  • Incidence of reported adverse events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    Descriptive statistics of the type and frequency of all adverse events will be generated, including 95% confidence intervals.

  • Incidence of changes in CBC/diff, blood chemistry, and lipids [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Study agent/metabolite levels [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    The Spearman correlation coefficient will be calculated to evaluate the correlation between biomarker changes and study agent/metabolite levels. Linear regression techniques will be used to adjust for potential confounders, e.g. age and BMI.


Enrollment: 46
Study Start Date: June 2011
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basic Science (resveratrol)
Patients receive resveratrol PO QD for 12 weeks.
Drug: resveratrol
Given PO
Other: laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370889

Locations
United States, Arizona
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Investigators
Principal Investigator: Hsiao-Hui (Sherry) Chow University of Arizona Health Sciences Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01370889     History of Changes
Obsolete Identifiers: NCT02022332
Other Study ID Numbers: NCI-2011-02593, NCI-2011-02593, CDR0000701405, 10-0653-04, UAZ08-12-01, P30CA023074, N01CN35158
Study First Received: June 9, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014