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

Raisio Group

Status: Completed

Conditions: Hyperlipidemias; Dyslipidemias; Hypercholesterolemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Plant stanol ester

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03284918

MFRA004

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups, including a placebo group

Plant stanol ester

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Plant stanol ester

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Placebo