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Completed

NCT Number: NCT00920894

Effect of Plant Stanol Esters on Blood Lipids

This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Life Sciences Ltd

Vuokatti, 88610, Finland

About this study

The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.

This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elevated blood lipids
  • Body Mass Index < 35 kg/m2
  • Stable body weight

Exclusion criteria

  • Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
  • Severe obesity
  • Hyperglycemia
  • Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
  • Hepatic, kidney or thyroid disease or disorder
  • Pregnancy or breast feeding
  • Severe intolerance or allergy to any ingredient of test product

Treatment and study plan

Plant stanol ester

Dietary Supplement

the effect of plant stanol esters on plasma lipids

Primary outcomes

  1. plasma lipids

    Time frame: 10 weeks

Secondary outcomes

  1. plasma lipoprotein lipids non-cholesterol sterols

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Clinical Life Sciences Ltd.

Other

Registry information

Official study title

The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 15, 2009
Registry last updated
Nov 5, 2009

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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