Serum Cholesterol Reduction Efficacy of Biscuit With 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: Other; Industry

Identifiers

NCT02331043

CL 2012_034

Details and patient eligibility

About

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.

Enrollment: 119 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
• fasting serum triglyceride levels below 3.0 mmol/l
• normal liver, kidney and thyroid function
• no lipid lowering medication
• no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases

Exclusion criteria

• alcohol abuse (> 4 portion/per day)
• pregnancy
• use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 2 patient groups, including a placebo group

Placebo biscuit

Placebo Comparator group

Description:

Biscuit without plant stanol ester

Treatment:

Dietary Supplement: Placebo

Plant stanol ester biscuit

Experimental group

Description:

Biscuit with plant stanol esters

Treatment:

Dietary Supplement: Plant stanol ester