A Study on the Effects of Soy Protein on Blood Lipids in... | NCT00945737

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

NCT00945737

Sponsor

Solae, LLC

Status

Completed

Last Update Posted

Jun 7, 2012Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hypercholesterolemia

Interventions

Soy protein; 25 grams/day
Control protein

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jul 21, 2009

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2012

Last Update Posted Date

Jun 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Soy protein	Active Comparator		Dietary Supplement: Soy protein; 25 grams/day
Milk protein	Placebo Comparator		Dietary Supplement: Control protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soy protein; 25 grams/day	Dietary Supplement	Soy protein	Soy protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in other lipid levels and other related biomarkers		4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Reeves, DO	Provident Clinical Research	Principal Investigator
Mano Patri, MD	Provident Clinical Research, Addison, IL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Provident Clinical Research		Addison	Illinois	60101	United States
Provident Clinical Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21122701	Derived	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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D010940	Plant Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D014674	Plant Proteins, Dietary