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

This study has been completed.
Sponsor:
Collaborator:
Solae, LLC
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00661856
First received: April 17, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 17, 2008
April 17, 2008
January 2001
January 2004   (final data collection date for primary outcome measure)
Bone Mineral Density [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Physical Performance Indices [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
The Effect of Increased Soy Protein Intake on Bone Metabolism

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
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 Name: genistein, daidzein, glycetein
  • Active Comparator: 1
    Soy Protein group 25g of Soy protein with no Isoflavones
    Intervention: Dietary Supplement: Soy protein
  • Experimental: 2
    Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones
    Intervention: Dietary Supplement: Soy protein
  • Placebo Comparator: 3
    25g of Milk protein
    Intervention: Dietary Supplement: Soy protein
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
January 2004
January 2004   (final data collection date for primary outcome measure)

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
Female
55 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00661856
0012254
Yes
J C Gallagher, Creighton University Medical Center
Creighton University
Solae, LLC
Principal Investigator: J C Gallagher Creighton University Medical Center
Creighton University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP