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Completed

NCT Number: NCT00661856

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

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.

Completed

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Key information

Age range

55 year–72 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soy protein

Dietary Supplement

25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months

Other names: genistein, daidzein, glycetein

Primary outcomes

  1. Bone Mineral Density

    Time frame: 24 months

Secondary outcomes

  1. Physical Performance Indices

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • Solae, LLC

Registry information

Official study title

The Effect of Increased Soy Protein Intake on Bone Metabolism

Acronym: SoyPTI

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Apr 21, 2008
Registry last updated
Apr 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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