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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
WD-PS intervention phase
PS-Ester intervention phase
placebo
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Richarson Centre for Funtional Foods and Nutraceuticals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Water dispersible Plant Sterol (WD-PS)

Esterified plant sterol (PS-Ester)

placebo

Arm Description

WD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol

PS-Ester enriched dairy product (2g/d free plant sterol)

100 g/d yogurt with no added plant sterol

Outcomes

Primary Outcome Measures

Lipid Profile

Secondary Outcome Measures

Full Information

First Posted
November 17, 2011
Last Updated
December 20, 2011
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01478789
Brief Title
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
Official Title
Naturalis Clinical Trial for a Novel Phytosterol Formulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water dispersible Plant Sterol (WD-PS)
Arm Type
Experimental
Arm Description
WD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol
Arm Title
Esterified plant sterol (PS-Ester)
Arm Type
Experimental
Arm Description
PS-Ester enriched dairy product (2g/d free plant sterol)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
100 g/d yogurt with no added plant sterol
Intervention Type
Dietary Supplement
Intervention Name(s)
WD-PS intervention phase
Intervention Description
2g/d of free plant sterol in 100g yogurt
Intervention Type
Dietary Supplement
Intervention Name(s)
PS-Ester intervention phase
Intervention Description
2g/d of free plant sterol in 100g yogurt
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
100g/d yogurt with no added plant sterol
Primary Outcome Measure Information:
Title
Lipid Profile
Time Frame
Change from Baseline in lipid profile at 4 weeks (end of the phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Richarson Centre for Funtional Foods and Nutraceuticals
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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