Expired Study
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Rochester, Minnesota 55905


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

CDR0000581219


NCT ID:

NCT00611104


Secondary ID:

P30CA015083


Study Acronym:


Brief Title:

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


Official Title:

Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Janet E. Olson, PhD
Principal Investigator
Mayo Clinic

Study Dates

Start Date:May 2008
Completion Date:August 22, 2014
Completion Type:Actual
Primary Completion Date:August 22, 2014
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 4, 2019
First Received Date:February 7, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Bioavailability of the freeze-dried table grape powder in humans
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:standardized freeze-dried table grape powder
Intervention Type:Other
Name:laboratory biomarker analysis
Intervention Type:Other
Name:pharmacological study

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Study Population: 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
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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