RATIONALE: Eating a diet rich in soy foods appears to reduce the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent the development of cancer.

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.

Condition	Treatment or Intervention
general prevention of cancer	Drug: soy protein isolate

Further Study Details: 

OBJECTIVES: I. Determine the effect of varying the dietary intake of soy nuts on plasma levels and urinary excretion of isoflavones.

II. Determine the effects of different food composition, along with age and gender of subjects, on plasma levels and urinary excretion of isoflavones.

PROTOCOL 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 miso soup 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Healthy women and men

--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

--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

Ohio
      Children's Hospital Medical Center - Cincinnati, Cincinnati,  Ohio,  45229-3039,  United States

Study chairs or principal investigators

Kenneth Setchell,  Study Chair,  Children's Hospital Medical Center - Cincinnati   

Study ID Numbers:  CDR0000065832; UCMC-CHMC-91-5-3; NCI-P97-0117
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003100
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08