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

The Effect of Increased Soy Protein Intake on Bone Metabolism

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00661856

Acronym

SoyPTI

Enrollment

203

Registered

2008-04-21

Start date

2001-01-31

Completion date

2004-01-31

Last updated

2008-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Soy Isoflavones, Bone Mineral Density, Post menopausal women

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTSoy protein

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 72 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bone Mineral Density	24 months

Secondary

Measure	Time frame
Physical Performance Indices	24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026