Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 2/9/2018 |
| Start Date: | May 2008 |
| End Date: | December 2018 |
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.
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.
- 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.
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
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