Skip to content

Soy and Isoflavones Effect on Bone

Soy Proteins and Isoflavones Impact Bone Mineral Density in Older Women

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00668447
Enrollment
97
Registered
2008-04-29
Start date
2001-11-30
Completion date
2005-06-30
Last updated
2008-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

bone density, bone loss, postmenopausal

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTSoy Isolate

20 grams of powder mixed in beverages or food daily for one year

DIETARY_SUPPLEMENTControl protein

20 grams of powder mixed in beverages or food daily for one year

DIETARY_SUPPLEMENTNovasoy isoflavones

3 tablets daily for one year

DIETARY_SUPPLEMENTPlacebo tablets

3 tablets daily for one year

Sponsors

University of Connecticut
CollaboratorOTHER
United States Department of Agriculture (USDA)
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Bone turnover markersbaseline, 3 months, and 1 year

Secondary

MeasureTime frame
Bone Mineral DensityBaseline, 6 and 12 months
Quality of life measured by Medical Outcomes Short FormBaseline, 6 and 12 months
Medication Side Effects3 , 6, 9, and 12 months
Adherence to dietary intervention through the use of 24-hour recall3, 6, 9, and 12 months
Long-term medication behavior self-efficacy scale3, 6, 9, and 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026