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

Naturalis Clinical Trial for a Novel Phytosterol Formulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01478789
Enrollment
47
Registered
2011-11-23
Start date
2010-09-30
Completion date
2011-10-31
Last updated
2011-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

DIETARY_SUPPLEMENTWD-PS intervention phase

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

DIETARY_SUPPLEMENTPS-Ester intervention phase

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

DIETARY_SUPPLEMENTplacebo

100g/d yogurt with no added plant sterol

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Lipid ProfileChange from Baseline in lipid profile at 4 weeks (end of the phase)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026