Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women

Breast Cancer Clinical Trial

Official title:

Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611104
• Other study ID #: CDR0000581219
• Secondary ID: P30CA015083MC053
• Status: Completed
• Start date: May 2008
• Est. completion date: August 22, 2014

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood and urine in the laboratory from participants receiving freeze-dried table grape powder may help doctors understand the effect of this drug on blood estrogen levels.

PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on blood estrogen levels in postmenopausal women.

Description:

OBJECTIVES:

• To measure the change in levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates in postmenopausal women after 6 weeks of daily ingestion of 94 grams of freeze-dried table grape powder.

• To conduct bioavailability research on the freeze-dried table grape powder in humans through the analysis of participants' blood and urine samples.

OUTLINE: Participants receive oral freeze-dried table grape powder once daily on days 1-42 in addition to their usual diet. Treatment continues in the absence of toxicity.

Participants undergo blood sample collection at baseline, periodically after the first dose, and on the last day of the study for pharmacokinetic and bioavailability analysis. Samples are examined by mass spectrometry to measure plasma levels of estrone (E1), estradiol, E1-conjugates, E1-sulfates, testosterone, and androstenedione. Participants also undergo spot urine collection and weight and height measurement periodically during study.

Participants complete food diaries on days 1-3, 21-23, and 40-42 to assess their intake of grapes, grape juice, and red wine and to examine the constancy of their caloric intake over the course of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 22, 2014
• Est. primary completion date: August 22, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Participant in the Mayo Mammography Health Study

• Has consented to provide baseline mammogram for digitization

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Female

• Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months)

• Able to give informed consent and complete food records alone or with assistance

• Willing to provide research blood and urine samples

• Must be a non-smoker

• Willing to maintain current weight

• No history of breast ductal carcinoma in situ or any other cancer, except basal cell or squamous cell skin cancer or lobular carcinoma in situ

• No history of allergic or other adverse reaction to grapes

• No history of diabetes or glucose intolerance

PRIOR CONCURRENT THERAPY:

• No concurrent hormone therapy, including estradiol, estrone, or progestins

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Dietary Supplement:
• standardized freeze-dried table grape powder

Other:
• laboratory biomarker analysis

• pharmacological study

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates
Primary	Bioavailability of the freeze-dried table grape powder in humans