A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
PRV-08009
A Randomized, Controlled Parallel Study to Evaluate the Effects of a Non-Commercial Soy Protein Product on Fecal Bile Acids and Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
1 other identifier
interventional
60
1 country
2
Brief Summary
The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2009
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedJune 7, 2012
June 1, 2012
4 months
July 21, 2009
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
4 weeks
Secondary Outcomes (1)
Changes in other lipid levels and other related biomarkers
4 weeks
Study Arms (2)
Soy protein
ACTIVE COMPARATORMilk protein
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female
- years of age
- Fasting LDL-Cholesterol level borderline to high range taking no cholesterol lowering medications
- otherwise judged to be in good health, willing to maintain a stable body weight and follow the TLC diet throughout the trial.
You may not qualify if:
- CHD or CHD risk equivalent
- Pregnancy
- Food allergy or sensitivity to soy or milk protein
- Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
- Poorly controlled hypertension
- Cancer treated within prior 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solae, LLClead
Study Sites (2)
Provident Clinical Research
Addison, Illinois, 60101, United States
Provident Clinical Research
Bloomington, Indiana, 47403, United States
Related Publications (1)
Maki KC, Butteiger DN, Rains TM, Lawless A, Reeves MS, Schasteen C, Krul ES. Effects of soy protein on lipoprotein lipids and fecal bile acid excretion in men and women with moderate hypercholesterolemia. J Clin Lipidol. 2010 Nov-Dec;4(6):531-42. doi: 10.1016/j.jacl.2010.09.001. Epub 2010 Oct 1.
PMID: 21122701DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Reeves, DO
Provident Clinical Research
- PRINCIPAL INVESTIGATOR
Mano Patri, MD
Provident Clinical Research, Addison, IL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 24, 2009
Study Start
April 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
June 7, 2012
Record last verified: 2012-06