NCT00366860

Brief Summary

A study was designed with two specific aims: (1) to assess the effect of soy bread, compared with wheat bread, on markers of bone metabolism and cardiovascular health, and (2) to evaluate whether soy bread consumption affects the metabolism of phytoestrogens. To answer Aim 1, a double-blind randomized crossover trial was conducted. Individuals with an ability to metabolize a specific isoflavone, daidzein, consumed 3 slices of bread (either soy or wheat) daily over a 12-week period. After a 4-week wash-out period, subjects consumed 3 slices/day of the other type of bread. Markers of bone metabolism and cardiovascular health were evaluated before and after each time period. To answer Aim 2, individuals who did not metabolize daidzein at baseline entered a double-blind randomized trial of soy bread with or without fructooligosaccharide (a type of dietary fiber) over an 8-week period. Subjects were evaluated regarding their ability to metabolize daidzein to equol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1

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

January 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

August 17, 2006

Last Update Submit

December 1, 2014

Conditions

OsteoporosisCardiovascular Diseases

Keywords

soyisoflavonesbone resorptionosteogenesisdiethyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • deoxypyridinoline

    Urinary deoxypyridinoline

    12 weeks

Secondary Outcomes (1)

  • N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, cholesterol, triglycerides, apolipoproteins, C-reactive protein, HbA1c

    12 weeks

Study Arms (2)

Soy bread

EXPERIMENTAL

Soy bread (75-100 mg isoflavone/day) for 12 weeks

Behavioral: Soy bread

Wheat bread

ACTIVE COMPARATOR

Wheat bread for 12 weeks

Behavioral: Soy bread

Interventions

Soy breadBEHAVIORAL
Soy breadWheat bread

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women and men who were 50 years of age or older.

You may not qualify if:

  • Allergy to soy, wheat, and/or nuts. Use of hormone replacement therapy within the past 6 months. Diagnosis of osteoporosis or use of bone loss medications. Use of drugs within the past 3 months which increase the risk of osteoporosis. End-stage renal disease or other nephropathies. Chemotherapy within the past 6 months. Active gastrointestinal disorders. Diagnosis of thyroid disorder. Use of cholesterol-lowering medications within the past month. Vitamin, mineral, protein, and/or calorie deficiency. Alcoholism, acute or chronic hepatitis, cirrhosis. Use of systemic antibiotics within the past 6 months. Currently under dietary restrictions that would conflict with the intervention. Anticipated mental or physical incapability of adhering to the dietary protocol during the time period of the study (e.g. expected travel).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

OsteoporosisCardiovascular DiseasesBone ResorptionHyperlipidemias

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Mary A.M. Rogers, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

January 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)