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

University of Manitoba47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

WD-PS intervention phaseDIETARY_SUPPLEMENT

2g/d of free plant sterol in 100g yogurt

PS-Ester intervention phaseDIETARY_SUPPLEMENT

2g/d of free plant sterol in 100g yogurt

placeboDIETARY_SUPPLEMENT

100g/d yogurt with no added plant sterol

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Richarson Centre for Funtional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Lipid Profile

Time frame: Change from Baseline in lipid profile at 4 weeks (end of the phase)

Data from ClinicalTrials.gov

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