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

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias
• Interventions: Dietary Supplement: Plant stanol ester; Dietary Supplement: Placebo

• Registration Number: NCT03284918
• Lead Sponsor: Raisio Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Status Verified: 2017-09
• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-13
• Last Update Submitted: 2017-09-13
• Study First Posted: 2017-09-15
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plant stanol ester	Plant stanol ester	Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).
Placebo	Placebo	Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).

Primary Outcome Measures

Name	Time	Method
Percentage change in serum LDL cholesterol	4 weeks

Secondary Outcome Measures

Name	Time	Method
Absolute change in serum LDL cholesterol (mmol/l)	4 weeks
Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides	4 weeks