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

University of Manitoba

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: WD-PS intervention phase; Dietary Supplement: placebo; Dietary Supplement: PS-Ester intervention phase

Study type: Interventional

Funder types: Other

Identifiers

NCT01478789

B2010:096

Details and patient eligibility

About

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.

Full description

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

Enrollment: 47 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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47 participants in 3 patient groups, including a placebo group

Water dispersible Plant Sterol (WD-PS)

Experimental group

Description:

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

Treatment:

Dietary Supplement: WD-PS intervention phase

Esterified plant sterol (PS-Ester)

Experimental group

Description:

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

Treatment:

Dietary Supplement: PS-Ester intervention phase

placebo

Placebo Comparator group

Description:

100 g/d yogurt with no added plant sterol

Treatment:

Dietary Supplement: placebo