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Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices

NCT ID: NCT00661856

Last Updated: 2008-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-01-31

Brief Summary

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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.

Detailed Description

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Post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. A decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. There is no evidence of its effects on physical performance.

The aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral Density and physical performance indices in post menopausal women over a duration of 2 years.

Conditions

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Osteoporosis

Keywords

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Soy Isoflavones, Bone Mineral Density, Post menopausal women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Soy Protein group 25g of Soy protein with no Isoflavones

Group Type ACTIVE_COMPARATOR

Soy protein

Intervention Type DIETARY_SUPPLEMENT

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

2

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

Group Type EXPERIMENTAL

Soy protein

Intervention Type DIETARY_SUPPLEMENT

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

3

25g of Milk protein

Group Type PLACEBO_COMPARATOR

Soy protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Soy protein

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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genistein, daidzein, glycetein

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

72 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Solae, LLC

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University Medical Center

Principal Investigators

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J C Gallagher

Role: PRINCIPAL_INVESTIGATOR

Creighton University Medical Center

Locations

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Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15167308 (View on PubMed)

Other Identifiers

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0012254

Identifier Type: -

Identifier Source: org_study_id