Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

Raisio Group155 enrolled

Overview

The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

155

Conditions

Hypercholesterolemia Hyperlipidemias Dyslipidemias

Interventions

1.6 g plant stanolsOTHER

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols

2 g plant stanolsOTHER

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols

1.6 g plant stanols and camelina oilOTHER

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI \< 30 kg/m2 * moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l) * serum triglycerides \< 3 mmol/l. * normal liver, kidney and thyroid function * subjects must voluntarily sign the informed consent Exclusion Criteria: * use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention * lipid lowering medication * history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases * pregnancy or lactation * alcohol abuse * subjects with intolerance to any ingredient of the test products

Outcomes

Primary Outcomes

Percentual change in serum LDL-cholesterol

Percentual change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups

Time frame: 4 weeks

Absolute change in serum LDL-cholesterol

Absolute change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups, mmol/l

Time frame: 4 weeks

Secondary Outcomes

Percentual change in serum total cholesterol

Percentual change \[end of intervention - start of intervention\] in serum total cholesterol between experimental and placebo groups

Time frame: 4 weeks

Absolute change in serum total cholesterol

Absolute change \[end of intervention - start of intervention\] in serum total cholesterol between experimental and placebo groups, mmol/l

Time frame: 4 weeks

Percentual change in serum non-HDL cholesterol

Percentual change \[end of intervention - start of intervention\] in serum nonHDL cholesterol between experimental and placebo groups

Time frame: 4 weeks

Absolute change in serum non-HDL cholesterol

Absolute change \[end of intervention - start of intervention\] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l

Time frame: 4 weeks

Percentual change in serum triglycerides

Percentual change \[end of intervention - start of intervention\] in serum triglycerides between experimental and placebo groups

Data from ClinicalTrials.gov

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