Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women
|ClinicalTrials.gov Identifier: NCT00611104|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2008
Last Update Posted : February 7, 2018
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 or disease||Intervention/treatment|
|Breast Cancer||Dietary Supplement: standardized freeze-dried table grape powder Other: laboratory biomarker analysis Other: pharmacological study|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates
- Bioavailability of the freeze-dried table grape powder in humans
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611104
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Janet E. Olson, PhD||Mayo Clinic|