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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Peter Jones, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01478789
First received: November 17, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypercholesterolemia
 Dietary Supplement: WD-PS intervention phase
Dietary Supplement: PS-Ester intervention phase
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Naturalis Clinical Trial for a Novel Phytosterol Formulation

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Lipid Profile [ Time Frame: Change from Baseline in lipid profile at 4 weeks (end of the phase) ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Water dispersible Plant Sterol (WD-PS)
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
2g/d of free plant sterol in 100g yogurt
Experimental: Esterified plant sterol (PS-Ester)
PS-Ester enriched dairy product (2g/d free plant sterol)
 Dietary Supplement: PS-Ester intervention phase
2g/d of free plant sterol in 100g yogurt
Placebo Comparator: placebo
100 g/d yogurt with no added plant sterol
 Dietary Supplement: placebo
100g/d yogurt with no added plant sterol

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478789

Locations
Canada, Manitoba
Richarson Centre for Funtional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Peter Jones, Director of the Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
ClinicalTrials.gov Identifier: NCT01478789     History of Changes
Other Study ID Numbers: B2010:096
Study First Received: November 17, 2011
Last Updated: December 20, 2011
Health Authority: Chile: Nuturalis S.A.

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013