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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000581219 | Other Identifier | Sponsor Protocol Number | |
| 06-002061 | Other Identifier | Mayo Clinic Institutional Review Board |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standardized freeze-dried table grape powder | Dietary Supplement | |||
| laboratory biomarker analysis | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates | ||
| Bioavailability of the freeze-dried table grape powder in humans |
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DISEASE CHARACTERISTICS:
Participant in the Mayo Mammography Health Study
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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PATIENT CHARACTERISTICS:
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| Name | Affiliation | Role |
|---|---|---|
| Janet E. Olson, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |