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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00611104
First received: February 7, 2008
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  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.


Condition Intervention
Breast Cancer
 Dietary Supplement: standardized freeze-dried table grape powder
Other: laboratory biomarker analysis
Other: pharmacological study

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates [ Designated as safety issue: No ]
  • Bioavailability of the freeze-dried table grape powder in humans [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611104

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Janet E. Olson, PhD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Janet Olson, Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00611104     History of Changes
Other Study ID Numbers: CDR0000581219, P30CA015083, MC0536, 06-002061
Study First Received: February 7, 2008
Last Updated: February 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013