Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias
• Interventions: Other: Placebo; Other: 1.6 g plant stanols and camelina oil; Other: 2 g plant stanols; Other: 1.6 g plant stanols; Other: 2 g plant stanols and camelina oil

• Registration Number: NCT02628990
• Lead Sponsor: Raisio Group

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-08
• Study Completion: 2005-11
• Status Verified: 2015-12
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-09
• Last Update Submitted: 2015-12-09
• Study First Posted: 2015-12-11
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A placebo yoghurt drink, consumed with a meal daily for 4 weeks
1.6 g plant stanols and camelina oil	1.6 g plant stanols and camelina oil	A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks
2 g plant stanols	2 g plant stanols	A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks
1.6 g plant stanols	1.6 g plant stanols	A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks
2 g plant stanols and camelina oil	2 g plant stanols and camelina oil	A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Absolute change in serum LDL-cholesterol	4 weeks	Absolute change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups, mmol/l
Percentual change in serum LDL-cholesterol	4 weeks	Percentual change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups

Secondary Outcome Measures

Name	Time	Method
Percentual change in serum total cholesterol	4 weeks	Percentual change \[end of intervention - start of intervention\] in serum total cholesterol between experimental and placebo groups
Absolute change in serum triglycerides	4 weeks	Absolute change \[end of intervention - start of intervention\] in serum triglycerides between experimental and placebo groups, mmol/l
Absolute change in serum total cholesterol	4 weeks	Absolute change \[end of intervention - start of intervention\] in serum total cholesterol between experimental and placebo groups, mmol/l
Percentual change in serum non-HDL cholesterol	4 weeks	Percentual change \[end of intervention - start of intervention\] in serum nonHDL cholesterol between experimental and placebo groups
Percentual change in serum triglycerides	4 weeks	Percentual change \[end of intervention - start of intervention\] in serum triglycerides between experimental and placebo groups
Absolute change in serum non-HDL cholesterol	4 weeks	Absolute change \[end of intervention - start of intervention\] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l