Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices (SoyPTI)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soy protein
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Soy Isoflavones, Bone Mineral Density, Post menopausal women
Eligibility 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
Sites / Locations
- Creighton University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Soy Protein group 25g of Soy protein with no Isoflavones
Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones
25g of Milk protein
Outcomes
Primary Outcome Measures
Bone Mineral Density
Secondary Outcome Measures
Physical Performance Indices
Full Information
NCT ID
NCT00661856
First Posted
April 17, 2008
Last Updated
April 17, 2008
Sponsor
Creighton University
Collaborators
Solae, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00661856
Brief Title
Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
Acronym
SoyPTI
Official Title
The Effect of Increased Soy Protein Intake on Bone Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Creighton University
Collaborators
Solae, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Soy Isoflavones, Bone Mineral Density, Post menopausal women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Soy Protein group 25g of Soy protein with no Isoflavones
Arm Title
2
Arm Type
Experimental
Arm Description
Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
25g of Milk protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy protein
Other Intervention Name(s)
genistein, daidzein, glycetein
Intervention Description
25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months
Primary Outcome Measure Information:
Title
Bone Mineral Density
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Physical Performance Indices
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J C Gallagher
Organizational Affiliation
Creighton University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15167308
Citation
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. doi: 10.1097/01.gme.0000097845.95550.71.
Results Reference
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Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
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