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A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia (PRV-08009)

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Soy protein; 25 grams/day

Control protein

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring hypercholesterolemia, cholesterol, soy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female
18-79 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.

Exclusion Criteria:

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

Sites / Locations

Provident Clinical Research
Provident Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Soy protein

Milk protein

Arm Description

Outcomes

Primary Outcome Measures

The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C

Secondary Outcome Measures

Changes in other lipid levels and other related biomarkers

Full Information

NCT ID

NCT00945737

First Posted

July 21, 2009

Last Updated

June 6, 2012

Sponsor

Solae, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00945737

Brief Title

A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia

Acronym

PRV-08009

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Solae, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

hypercholesterolemia, cholesterol, soy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Soy protein

Arm Type

Active Comparator

Arm Title

Milk protein

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Soy protein; 25 grams/day

Intervention Description

Soy protein

Intervention Type

Dietary Supplement

Intervention Name(s)

Control protein

Intervention Description

Milk protein

Primary Outcome Measure Information:

Title

The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Changes in other lipid levels and other related biomarkers

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female 18-79 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Reeves, DO

Organizational Affiliation

Provident Clinical Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mano Patri, MD

Organizational Affiliation

Provident Clinical Research, Addison, IL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Provident Clinical Research

City

Addison

State/Province

Illinois

ZIP/Postal Code

60101

Country

United States

Facility Name

Provident Clinical Research

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47403

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21122701

Citation

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.

Results Reference

derived

Learn more about this trial

A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia

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