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
  Purpose

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.


Condition Intervention
Osteoporosis
Dietary Supplement: Soy protein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Increased Soy Protein Intake on Bone Metabolism

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physical Performance Indices [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 203
Study Start Date: January 2001
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Soy Protein group 25g of Soy protein with no Isoflavones
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
Experimental: 2
Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones
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
Placebo Comparator: 3
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
Other Name: genistein, daidzein, glycetein

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.

  Eligibility

Ages Eligible for Study:   55 Years to 72 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661856

Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Solae, LLC
Investigators
Principal Investigator: J C Gallagher Creighton University Medical Center
  More Information

Publications:
Responsible Party: J C Gallagher, Creighton University Medical Center
ClinicalTrials.gov Identifier: NCT00661856     History of Changes
Other Study ID Numbers: 0012254
Study First Received: April 17, 2008
Last Updated: April 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Soy Isoflavones, Bone Mineral Density, Post menopausal women

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014