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

Osteoporosis Clinical Trial

— SoyPTI  

Official title:

The Effect of Increased Soy Protein Intake on Bone Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661856
• Other study ID #: 0012254
• Status: Completed
• Phase: N/A
• First received: April 17, 2008
• Last updated: April 17, 2008
• Start date: January 2001
• Est. completion date: January 2004

Study information

• Verified date: April 2008
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 72 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
United States	Creighton University Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Solae, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density		24 months	Yes
Secondary	Physical Performance Indices		24 months	Yes