Skip to main content
OpenTrials
Completed

NCT Number: NCT02221297

Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male and female over 18 years old
  • serum LDL cholesterol > 3.0 mmol/L
  • BMI < 35
  • subjects must voluntarily sign the informed consent

Exclusion criteria

  • subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
  • subjects with any hepatic or renal disorder according to medical history
  • subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
  • subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
  • subjects who have history of temporal ischemic attack or stroke within six months prior to screening
  • subjects who have a history of cancer or other malignant disease within the past five years
  • subjects who are consuming more than 15 portions of alcohol / week
  • subjects who are pregnant or lactating
  • subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
  • subjects with intolerance to any ingredient of the test product

Treatment and study plan

Supplement product with plant stanol ester

Dietary Supplement

2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

Primary outcomes

  1. Proportional change in serum LDL cholesterol

    Time frame: 3 to 4 weeks

    Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.

Secondary outcomes

  1. Proportional change in total cholesterol

    Time frame: 3 to 4 weeks

    Proportional change [end of intervention - start of intervention] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.

  2. Proportional change in non-HDL-cholesterol

    Time frame: 3 to 4 weeks

    Proportional change [end of intervention - start of intervention] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.

  3. Proportional change in serum triglycerides

    Time frame: 3 to 4 weeks

    Proportional change [end of intervention - start of intervention] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.

  4. Proportional change in lipids in all study participants

    Time frame: 3 to 4 weeks

    Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis)

  5. Proportional change in lipids in subjects without metabolic derangements

    Time frame: 3 to 4 weeks

    Proportional change [end of intervention - start of intervention] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome)

Sponsors and collaborators

Lead sponsor

Raisio Group

Industry

Collaborators

  • Clinical Research Institute HUCH Ltd

Registry information

Official study title

Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2014
Registry last updated
Oct 29, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.