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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: PS-Ester intervention phase; Dietary Supplement: placebo; Dietary Supplement: WD-PS intervention phase

• Registration Number: NCT01478789
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-02
• Study Completion: 2011-10
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-20
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lipid Profile	Change from Baseline in lipid profile at 4 weeks (end of the phase)

Trial Locations

Locations (1)

Richarson Centre for Funtional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada