Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women
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.
Dietary Supplement: standardized freeze-dried table grape powder
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract|
- 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 ]
|Study Start Date:||May 2008|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611104
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Janet E. Olson, PhD||Mayo Clinic|