Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
1996-10-31
Brief Summary
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PURPOSE: Clinical trial to determine the most effective amount and type of soy isoflavones needed in the diets of healthy men and women to prevent cancer.
Detailed Description
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OUTLINE: This is a two part study. In part I; participants are stratified according to menopausal status. In part II; participants are stratified according to gender and age (under 50 vs. over 50). Part I - Study participants are given 3 different amounts of toasted soy nuts separated by one month intervals. The sequence in which each amount is given is randomized. Blood and urine samples are taken to measure isoflavone levels. Part II - Study participants are given toasted soy nuts, soy milk, and tempeh on separate occasions separated by one month intervals. The sequence of each food is randomized. Blood and urine samples are taken to measure isoflavone levels.
PROJECTED ACCRUAL: 10 women, 5 premenopausal and 5 postmenopausal, will be accrued for part I of the study. 80 subjects, 40 women and 40 men, will be accrued for part II.
Conditions
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Keywords
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Study Design
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PREVENTION
Interventions
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soy isoflavones
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No chronic liver disease Renal: No chronic renal disease Cardiovascular: No chronic cardiovascular disease Pulmonary: No chronic pulmonary disease Other: No known allergy to soy proteins No consumption of soy protein within past week
PRIOR CONCURRENT THERAPY: Biologic therapy: No antibiotics within past 3 months Chemotherapy: Not specified Endocrine therapy: No oral contraceptive or hormone replacement therapy Radiotherapy: Not specified Surgery: Not specified Other: No medication likely to affect gastrointestinal, liver, or kidney function
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Principal Investigators
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Kenneth Setchell, PhD
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Locations
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Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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UCMC-CHMC-91-5-3
Identifier Type: -
Identifier Source: secondary_id
NCI-P97-0117
Identifier Type: -
Identifier Source: secondary_id
CDR0000065832
Identifier Type: -
Identifier Source: org_study_id