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Metabolic Fate and Plasma Kinetics of Dietary Soy Isoflavones


N/A
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Metabolic Fate and Plasma Kinetics of Dietary Soy Isoflavones


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.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Healthy women and men

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Kenneth Setchell, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati

Authority:

United States: Federal Government

Study ID:

CDR0000065832

NCT ID:

NCT00003100

Start Date:

October 1996

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039