Effect of Plant Stanol Esters on Blood Lipids

Clinical Life Sciences

Status: Completed

Conditions: Elevated Blood Lipids

Treatments: Dietary Supplement: plant stanol ester

Study type: Interventional

Funder types: Other

Identifiers

NCT00920894

Kainuu PlantStanol Ester Study

Details and patient eligibility

About

This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

Full description

The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.

This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Enrollment: 112 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated blood lipids
• Body Mass Index < 35 kg/m2
• Stable body weight

Exclusion criteria

• Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
• Severe obesity
• Hyperglycemia
• Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
• Hepatic, kidney or thyroid disease or disorder
• Pregnancy or breast feeding
• Severe intolerance or allergy to any ingredient of test product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups, including a placebo group

yoghurt type minidrink containing plant stanol ester

Experimental group

Treatment:

Dietary Supplement: plant stanol ester

yoghurt type minidrink without plant stanol ester

Placebo Comparator group

Treatment:

Dietary Supplement: plant stanol ester