An interventional study of Soy protein in Osteoporosis, sponsored by Creighton University. Completed at 1 site in United States. Open to female participants aged 55 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-21.
Sponsored by Creighton University · Not applicable, Interventional, and Treatment
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 203 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Creighton University is the lead sponsor of 126 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Soy Protein group 25g of Soy protein with no Isoflavones
Dietary Supplement: Soy protein
Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones
Dietary Supplement: Soy protein
25g of Milk protein
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
Also known as: genistein, daidzein, glycetein
Bone Mineral Density
Time frame: 24 months
Physical Performance Indices
Time frame: 24 months
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Creighton University