Efficacy of Plant Sterol-Fortified Dairy Product on Plasm... | NCT01478789

Studies
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans

NCT01478789

Sponsor

University of Manitoba

Status

Completed

Last Update Posted

Dec 21, 2011Estimated

Enrollment

47Actual

Phase

Not Applicable

Conditions

Hypercholesterolemia

Interventions

WD-PS intervention phase
PS-Ester intervention phase
placebo

Countries

Canada

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

Dec 2011

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

Sep 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Nov 17, 2011

First Submission Date that Met QC Criteria

Nov 21, 2011

First Posted Date

Nov 23, 2011Estimated

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

Dec 20, 2011

Last Update Posted Date

Dec 21, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Peter Jones, Director of the Richardson Centre for Functional Foods and Nutraceuticals, University of ManitobaPrincipal Investigator

Lead Sponsor

University of ManitobaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.

Detailed Description

Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

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

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Water dispersible Plant Sterol (WD-PS)	Experimental	WD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol	Dietary Supplement: WD-PS intervention phase
Esterified plant sterol (PS-Ester)	Experimental	PS-Ester enriched dairy product (2g/d free plant sterol)	Dietary Supplement: PS-Ester intervention phase
placebo	Placebo Comparator	100 g/d yogurt with no added plant sterol	Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WD-PS intervention phase	Dietary Supplement	2g/d of free plant sterol in 100g yogurt	Water dispersible Plant Sterol (WD-PS)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lipid Profile		Change from Baseline in lipid profile at 4 weeks (end of the phase)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individuals aged 19-60 yr
plasma LDL-C levels > 3.0mmol/l
TG < 4.5mmol/l
body mass index (BMI) between 20 and 30 kg/m2.

Exclusion Criteria:

history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
history of chronic use of alcohol (>2 drinks/d)
smoking
myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Richarson Centre for Funtional Foods and Nutraceuticals		Winnipeg	Manitoba	R3T 2N2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided