NCT00000613

Brief Summary

To determine the acceptability and benefits of use of a dietary supplement of the phytoestrogen, genistein, versus placebo on heart disease risk factors, bone density, and psychosocial outcomes in postmenopausal women.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1997

Longer than P75 for phase_2

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

February 29, 2016

Status Verified

December 1, 2005

First QC Date

October 27, 1999

Last Update Submit

February 26, 2016

Conditions

Bone DiseasesCardiovascular DiseasesCoronary DiseaseDepressionHeart DiseasesMyocardial IschemiaOsteoporosisPostmenopause

Interventions

dietary supplementsBEHAVIORAL
genisteinDRUG
diet, soy proteinsBEHAVIORAL

Eligibility Criteria

Age45 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Postmenopausal women, ages 45 to 74.

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

Sponsors & Collaborators

Related Publications (3)

  • Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake is associated with cardiovascular disease risk factors in postmenopausal women. J Nutr. 2001 Apr;131(4):1202-6. doi: 10.1093/jn/131.4.1202.

    PMID: 11285326BACKGROUND

  • Kritz-Silverstein D, Goodman-Gruen DL. Usual dietary isoflavone intake, bone mineral density, and bone metabolism in postmenopausal women. J Womens Health Gend Based Med. 2002 Jan-Feb;11(1):69-78. doi: 10.1089/152460902753473480.

    PMID: 11860727BACKGROUND

  • Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake and body composition in postmenopausal women. Menopause. 2003 Sep-Oct;10(5):427-32. doi: 10.1097/01.GME.0000058866.35869.B4.

    PMID: 14501604BACKGROUND

MeSH Terms

Conditions

Bone DiseasesCardiovascular DiseasesCoronary DiseaseDepressionHeart DiseasesMyocardial IschemiaOsteoporosis

Interventions

Dietary SupplementsGenisteinDietSoybean Proteins

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesVascular DiseasesBehavioral SymptomsBehaviorBone Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesIsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNutritional Physiological PhenomenaPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsSoy FoodsVegetable ProductsVegetables

Study Officials

  • Donna Kritz-Silverstein

    University of California, San Diego

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 1997

Study Completion

December 1, 2004

Last Updated

February 29, 2016

Record last verified: 2005-12