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Completed

NCT Number: NCT01478789

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

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.

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richarson Centre for Funtional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WD-PS intervention phase

Dietary Supplement

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

PS-Ester intervention phase

Dietary Supplement

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

Placebo

Dietary Supplement

100g/d yogurt with no added plant sterol

Primary outcomes

  1. Lipid Profile

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Naturalis Clinical Trial for a Novel Phytosterol Formulation

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2011
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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