Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dietary Soy Isoflavones for the Prevention of Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003100
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: June 2000

November 1, 1999
December 18, 2013
October 1996
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00003100 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dietary Soy Isoflavones for the Prevention of Cancer
Metabolic Fate and Plasma Kinetics of Dietary Soy Isoflavones

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.

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.

Interventional
Not Provided
Primary Purpose: Prevention
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: soy isoflavones
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
Not Provided
Not Provided

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003100
CDR0000065832, UCMC-CHMC-91-5-3, NCI-P97-0117
Not Provided
Not Provided
Children's Hospital Medical Center, Cincinnati
National Cancer Institute (NCI)
Study Chair: Kenneth Setchell, PhD Children's Hospital Medical Center, Cincinnati
National Cancer Institute (NCI)
June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP