NCT00661856

Brief Summary

The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2001

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

Enrollment Period

3 years

First QC Date

April 17, 2008

Last Update Submit

April 17, 2008

Conditions

Osteoporosis

Keywords

Soy Isoflavones, Bone Mineral Density, Post menopausal women

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    24 months

Secondary Outcomes (1)

  • Physical Performance Indices

    24 months

Study Arms (3)

1

ACTIVE COMPARATOR

Soy Protein group 25g of Soy protein with no Isoflavones

Dietary Supplement: Soy protein

2

EXPERIMENTAL

Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones

Dietary Supplement: Soy protein

3

PLACEBO COMPARATOR

25g of Milk protein

Dietary Supplement: Soy protein

Interventions

Soy proteinDIETARY_SUPPLEMENT

25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months

Also known as: genistein, daidzein, glycetein
123

Eligibility Criteria

Age55 Years - 72 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 55-75 years of age
  • at least 7 years post menopausal either spontaneous or surgical

You may not qualify if:

  • must not have used estrogen for atleast 2 months prior to entering study
  • must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids
  • osteoporosis (T-score\<-2.5)
  • BMI \<18 or \>34

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

  • Gallagher JC, Satpathy R, Rafferty K, Haynatzka V. The effect of soy protein isolate on bone metabolism. Menopause. 2004 May-Jun;11(3):290-8. doi: 10.1097/01.gme.0000097845.95550.71.

    PMID: 15167308BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Soybean ProteinsGenisteindaidzein

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and BeveragesIsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • J C Gallagher

    Creighton University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

January 1, 2001

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

US(1)