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

Study Overview
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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.

Official Title
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The Effect of Increased Soy Protein Intake on Bone Metabolism

Conditions
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Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Soy protein


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Soy Protein group 25g of Soy protein with no Isoflavones | Dietary Supplement: Soy protein<br>* 25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months<br>* Other names: genistein, daidzein, glycetein;|
| Experimental: 2<br>Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones | Dietary Supplement: Soy protein<br>* 25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months<br>* Other names: genistein, daidzein, glycetein;|
| Placebo Comparator: 3<br>25g of Milk protein | Dietary Supplement: Soy protein<br>* 25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months<br>* Other names: genistein, daidzein, glycetein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Performance Indices |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soy Isoflavones, Bone Mineral Density, Post menopausal women