Resveratrol in Postmenopausal Women With High Body Mass Index

Healthy, no Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370889
• Other study ID #: NCI-2011-02593
• Secondary ID: NCI-2011-02593CD
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2011
• Last updated: October 8, 2014
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT02022332

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease

Intervention

Drug:
• resveratrol
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Arizona Cancer Center - Tucson	Tucson	Arizona
United States	University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum estradiol levels in postmenopausal women with high BMI	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in serum estrone	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in serum testosterone	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in serum sex hormone-binding globulin (SHBG)	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in serum levels of insulin	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in serum levels of C-peptide	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in serum leptin	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in serum adiponectin	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in inflammatory markers, measured by serum C-reactive protein	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in urinary 8-iso-PGF2alpha	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Change in urinary 8OHdG	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.	From baseline to 12 weeks (post-intervention)	No
Secondary	Incidence of reported adverse events	Descriptive statistics of the type and frequency of all adverse events will be generated, including 95% confidence intervals.	Up to 12 weeks	Yes
Secondary	Incidence of changes in CBC/diff, blood chemistry, and lipids		Up to 12 weeks	No
Secondary	Study agent/metabolite levels	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.	Up to 12 weeks	No