Trial | NCT00661856  Report issue

Title

Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
The Effect of Increased Soy Protein Intake on Bone Metabolism

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    soybean ...

  • Study Participants

    203
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.
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.
Study Started
Jan 31
2001
Primary Completion
Jan 31
2004
Study Completion
Jan 31
2004
Last Update
Apr 21
2008
Estimate

Dietary Supplement Soy protein

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

  • Other names: genistein, daidzein, glycetein

1 Active Comparator

Soy Protein group 25g of Soy protein with no Isoflavones

2 Experimental

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

3 Placebo Comparator

25g of Milk protein

Criteria 

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
No Results Posted