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
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Dietary Supplement: Soy Isolate
Dietary Supplement: Control protein
Dietary Supplement: Novasoy isoflavones
Dietary Supplement: Placebo tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Soy Proteins and Isoflavones Impact Bone Mineral Density in Older Women

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Bone turnover markers [ Time Frame: baseline, 3 months, and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 97
Study Start Date: November 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Soy protein and isoflavone tablets
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: Novasoy isoflavones
3 tablets daily for one year
Active Comparator: 2
Soy protein and placebo tablets
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: Placebo tablets
3 tablets daily for one year
Active Comparator: 3
control protein and Isoflavone tablets
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
Placebo Comparator: 4
control protein and placebo tablets
Dietary Supplement: Control protein
20 grams of powder mixed in beverages or food daily for one year
Dietary Supplement: Placebo tablets
3 tablets daily for one year

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00668447

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
University of Connecticut
Investigators
Principal Investigator: Jane Kerstetter, PhD Department of Allied Health Sciences, University of Connecticut
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging
ClinicalTrials.gov Identifier: NCT00668447     History of Changes
Other Study ID Numbers: AG0102, USDA CONR-2001-00630
Study First Received: April 25, 2008
Last Updated: April 25, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
bone density
bone loss
postmenopausal

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

ClinicalTrials.gov processed this record on September 22, 2014