NCT00003100

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

September 6, 2004

Completed
Last Updated

December 19, 2013

Status Verified

June 1, 2000

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

soy isoflavonesDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Interventions

Soybean Proteins

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Kenneth Setchell, PhD

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 6, 2004

Study Start

October 1, 1996

Last Updated

December 19, 2013

Record last verified: 2000-06

Locations

US(1)