Soy and Isoflavones Effect on Bone

This study has been completed.
Sponsor:
Collaborator:
University of Connecticut
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00668447
First received: April 25, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 25, 2008
April 25, 2008
November 2001
June 2005   (final data collection date for primary outcome measure)
Bone turnover markers [ Time Frame: baseline, 3 months, and 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Bone Mineral Density [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life measured by Medical Outcomes Short Form [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Medication Side Effects [ Time Frame: 3 , 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Adherence to dietary intervention through the use of 24-hour recall [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Long-term medication behavior self-efficacy scale [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Soy and Isoflavones Effect on Bone
Soy Proteins and Isoflavones Impact Bone Mineral Density in Older Women

The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or soy isoflavones on bone mineral density in late postmenopausal women.

Although soy foods contain several components (isoflavones and amino acids) that could potentially have positive effects on bone health, there are few long term, large, clinical trials using soy as a means of improving bone mineral density. The objective of this study is to provide daily soy protein and isoflavones to healthy older women in order to answer three major questions:

  1. Does soy protein alone affect bone metabolism?
  2. Do isoflavones, given with soy protein, affect bone metabolism?
  3. What dose of isoflavones affects bone in older women?

We hypothesize that soy protein will have a beneficial effect on bone in older women compared to control protein. Further, we hypothesize that there will be an additional benefit to bone in women who receive soy protein plus isoflavones (at both doses) compared to soy protein alone.

Both control and soy proteins used in the study were isolates, meaning they were the highest concentration of protein (85-90% by weight) in order to minimize the volume of protein supplement that each woman was asked to ingest on a daily basis. The soy protein was an alcohol-washed, soy protein isolate containing 90% protein and negligible isoflavone (0.2 mg/g product). The control protein was a mix consisting of 50% protein from sodium caseinate, 25% protein from whey protein and 25% from egg white protein. The use of a mix of proteins as a control provides a more balanced level of amino acids, mimics the real life mix of proteins that humans typically consume, and avoids the unique characteristics of one source of protein. In order to maintain the dietary protein intake constant, the participant was counseled to decrease her intake of other sources of protein from primarily animal sources by approximately 3 ounces per day (the approximate equivalent of the protein powders). The isoflavones tablets each contained 57 mg of total isoflavone from primarily genistein, glycitein, and daidzein and their beta-glycosides.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
  • Dietary Supplement: Soy Isolate
    20 grams of powder mixed in beverages or food daily for one year
    Other Name: Pro Fam 930, 066-930
  • Dietary Supplement: Control protein
    20 grams of powder mixed in beverages or food daily for one year
  • Dietary Supplement: Novasoy isoflavones
    3 tablets daily for one year
  • Dietary Supplement: Placebo tablets
    3 tablets daily for one year
  • Experimental: 1
    Soy protein and isoflavone tablets
    Interventions:
    • Dietary Supplement: Soy Isolate
    • Dietary Supplement: Novasoy isoflavones
  • Active Comparator: 2
    Soy protein and placebo tablets
    Interventions:
    • Dietary Supplement: Soy Isolate
    • Dietary Supplement: Placebo tablets
  • Active Comparator: 3
    control protein and Isoflavone tablets
    Interventions:
    • Dietary Supplement: Control protein
    • Dietary Supplement: Novasoy isoflavones
  • Placebo Comparator: 4
    control protein and placebo tablets
    Interventions:
    • Dietary Supplement: Control protein
    • Dietary Supplement: Placebo tablets

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postmenopausal women 65 years old or older
  • Able to travel to the clinical sites for follow-up visits

Exclusion Criteria:

  • History of disease that may affect bone metabolism (including Paget's disease, primary hyperparathyroidism, osteomalacia, untreated hyperthyroidism, or multiple myeloma)
  • Cancer of any kind (except basal or squamous cell of skin) in past 5 years
  • Use of any of the following medications within the past 2 years: calcitonin, calcitriol, heparin, phenytoin, phenobarbital
  • Use at any time of bisphosphonates, long-term corticosteroids (over 6 months), methotrexate, or fluoride
  • Estimated creatinine clearance less than 50 ml/min
  • History of chronic liver disease or evidence of liver disease on screening
  • History of hip fracture
  • Known vertebral fracture within the past year
  • Vegans
Female
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668447
AG0102, USDA CONR-2001-00630
No
Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging
USDA Beltsville Human Nutrition Research Center
University of Connecticut
Principal Investigator: Jane Kerstetter, PhD Department of Allied Health Sciences, University of Connecticut
National Institute on Aging (NIA)
April 2008

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