Skip to main content
OpenTrials
Completed

NCT Number: NCT03284918

Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.

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–70 year

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

  • Serum total cholesterol 5.2-8.5 mmol/l
  • Serum triglycerides < 3 mmol/l
  • Signed written informed consent

Exclusion criteria

  • Abnormal liver, kidney and thyroid function
  • Use of lipid lowering medication
  • Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
  • History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
  • Diagnosed type 1 or type 2 diabetes requiring medical treatment
  • History of recent temporal ischemic attack or malignant diseases (< 5 yrs)
  • Celiac disease, or allergy or intolerance to the ingredients of the test products
  • Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
  • Subjects with alcohol abuse (> 4 portion per day)
  • Pregnancy or planned pregnancy or lactating

Treatment and study plan

Plant stanol ester

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Percentage change in serum LDL cholesterol

    Time frame: 4 weeks

Secondary outcomes

  1. Absolute change in serum LDL cholesterol (mmol/l)

    Time frame: 4 weeks

  2. Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Raisio Group

Industry

Collaborators

  • Oy Medfiles Ltd

Registry information

Official study title

Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2017
Registry last updated
Sep 15, 2017

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.