Resveratrol in Postmenopausal Women With High Body Mass Index

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01370889
First received: June 9, 2011
Last updated: October 8, 2014
Last verified: April 2014

June 9, 2011
October 8, 2014
June 2011
July 2012   (final data collection date for primary outcome measure)
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.
Change in serum estradiol levels from baseline (BL) to post-intervention (PI) in postmenopausal women with high BMI [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01370889 on ClinicalTrials.gov Archive Site
  • 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.
  • Change in other circulating sex-steroid hormones, including serum estrone, testosterone, and sex hormone-binding globulin (SHBG), from BL to PI [ Designated as safety issue: No ]
  • Change in serum levels of insulin and C-peptide from BL to PI [ Designated as safety issue: No ]
  • Change in adipocytokine expression and secretion, measured by serum leptin and adiponectin, from BL to PI [ Designated as safety issue: No ]
  • Change in inflammatory markers, measured by serum C-reactive protein, from BL to PI [ Designated as safety issue: No ]
  • Change in oxidative stress as measured by urinary 8-iso-PGF2α and 8OHdG, from BL to PI [ Designated as safety issue: No ]
  • Safety of resveratrol intervention as measured by reported adverse events and changes in CBC/diff, blood chemistry, and lipids [ Designated as safety issue: Yes ]
  • Correlation between biomarker changes and systemic resveratrol levels [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Resveratrol in Postmenopausal Women With High Body Mass Index
Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index

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.

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

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy, no Evidence of Disease
  • Drug: resveratrol
    Given PO
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Basic Science (resveratrol)
Patients receive resveratrol PO QD for 12 weeks.
Interventions:
  • Drug: resveratrol
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Female
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01370889
NCI-2011-02593, NCI-2011-02593, CDR0000701405, 10-0653-04, UAZ08-12-01, P30CA023074, N01CN35158
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Hsiao-Hui (Sherry) Chow University of Arizona Health Sciences Center
National Cancer Institute (NCI)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP