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

November 17, 2011
December 20, 2011
September 2010
February 2011   (final data collection date for primary outcome measure)
Lipid Profile [ Time Frame: Change from Baseline in lipid profile at 4 weeks (end of the phase) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01478789 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
Naturalis Clinical Trial for a Novel Phytosterol Formulation

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Dietary Supplement: WD-PS intervention phase
    2g/d of free plant sterol in 100g yogurt
  • Dietary Supplement: PS-Ester intervention phase
    2g/d of free plant sterol in 100g yogurt
  • Dietary Supplement: placebo
    100g/d yogurt with no added plant sterol
  • 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
    Intervention: Dietary Supplement: WD-PS intervention phase
  • Experimental: Esterified plant sterol (PS-Ester)
    PS-Ester enriched dairy product (2g/d free plant sterol)
    Intervention: Dietary Supplement: PS-Ester intervention phase
  • Placebo Comparator: placebo
    100 g/d yogurt with no added plant sterol
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
October 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
19 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01478789
B2010:096
Yes
Dr. Peter Jones, University of Manitoba
University of Manitoba
Not Provided
Not Provided
University of Manitoba
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP