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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:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00611104
First received: February 7, 2008
Last updated: April 7, 2014
Last verified: April 2014

February 7, 2008
April 7, 2014
May 2008
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00611104 on ClinicalTrials.gov Archive Site
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Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women
Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

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
Breast Cancer
  • Dietary Supplement: standardized freeze-dried table grape powder
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611104
CDR0000581219, P30CA015083, MC0536, 06-002061
Yes
Janet Olson, Ph.D., Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Janet E. Olson, PhD Mayo Clinic
Mayo Clinic
April 2014

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