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
  Purpose

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 Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: soy isoflavones

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Metabolic Fate and Plasma Kinetics of Dietary Soy Isoflavones

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 90
Study Start Date: October 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003100

Locations
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Study Chair: Kenneth Setchell, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003100     History of Changes
Other Study ID Numbers: CDR0000065832, UCMC-CHMC-91-5-3, NCI-P97-0117
Study First Received: November 1, 1999
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on July 26, 2014