NCT00668447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
Last Updated

April 29, 2008

Status Verified

April 1, 2008

Enrollment Period

3.6 years

First QC Date

April 25, 2008

Last Update Submit

April 25, 2008

Conditions

Osteoporosis

Keywords

bone densitybone losspostmenopausal

Outcome Measures

Primary Outcomes (1)

  • Bone turnover markers

    baseline, 3 months, and 1 year

Secondary Outcomes (5)

  • Bone Mineral Density

    Baseline, 6 and 12 months

  • Quality of life measured by Medical Outcomes Short Form

    Baseline, 6 and 12 months

  • Medication Side Effects

    3 , 6, 9, and 12 months

  • Adherence to dietary intervention through the use of 24-hour recall

    3, 6, 9, and 12 months

  • Long-term medication behavior self-efficacy scale

    3, 6, 9, and 12 months

Study Arms (4)

1

EXPERIMENTAL

Soy protein and isoflavone tablets

Dietary Supplement: Soy IsolateDietary Supplement: Novasoy isoflavones

2

ACTIVE COMPARATOR

Soy protein and placebo tablets

Dietary Supplement: Soy IsolateDietary Supplement: Placebo tablets

3

ACTIVE COMPARATOR

control protein and Isoflavone tablets

Dietary Supplement: Control proteinDietary Supplement: Novasoy isoflavones

4

PLACEBO COMPARATOR

control protein and placebo tablets

Dietary Supplement: Control proteinDietary Supplement: Placebo tablets

Interventions

Soy IsolateDIETARY_SUPPLEMENT

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

Also known as: Pro Fam 930, 066-930
12
Control proteinDIETARY_SUPPLEMENT

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

34
Novasoy isoflavonesDIETARY_SUPPLEMENT

3 tablets daily for one year

13
Placebo tabletsDIETARY_SUPPLEMENT

3 tablets daily for one year

24

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (4)

  • Evans EM, Racette SB, Van Pelt RE, Peterson LR, Villareal DT. Effects of soy protein isolate and moderate exercise on bone turnover and bone mineral density in postmenopausal women. Menopause. 2007 May-Jun;14(3 Pt 1):481-8. doi: 10.1097/01.gme.0000243570.78570.f7.

    PMID: 17213752BACKGROUND

  • Alekel DL, Germain AS, Peterson CT, Hanson KB, Stewart JW, Toda T. Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of perimenopausal women. Am J Clin Nutr. 2000 Sep;72(3):844-52. doi: 10.1093/ajcn/72.3.844.

    PMID: 10966908BACKGROUND

  • Arjmandi BH, Lucas EA, Khalil DA, Devareddy L, Smith BJ, McDonald J, Arquitt AB, Payton ME, Mason C. One year soy protein supplementation has positive effects on bone formation markers but not bone density in postmenopausal women. Nutr J. 2005 Feb 23;4:8. doi: 10.1186/1475-2891-4-8.

    PMID: 15727682BACKGROUND

  • Kenny AM, Mangano KM, Abourizk RH, Bruno RS, Anamani DE, Kleppinger A, Walsh SJ, Prestwood KM, Kerstetter JE. Soy proteins and isoflavones affect bone mineral density in older women: a randomized controlled trial. Am J Clin Nutr. 2009 Jul;90(1):234-42. doi: 10.3945/ajcn.2009.27600. Epub 2009 May 27.

    PMID: 19474141DERIVED

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jane Kerstetter, PhD

    Department of Allied Health Sciences, University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 29, 2008

Study Start

November 1, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 29, 2008

Record last verified: 2008-04

Locations

US(1)