Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

Study Overview
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Brief Summary
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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

Official Title
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The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations

Conditions
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Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Intervention / Treatment
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* Other: 1.6 g plant stanols
* Other: 2 g plant stanols
* Other: 1.6 g plant stanols and camelina oil
* Other: 2 g plant stanols and camelina oil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.6 g plant stanols<br>A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks | Other: 1.6 g plant stanols<br>* Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols<br>|
| Experimental: 2 g plant stanols<br>A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks | Other: 2 g plant stanols<br>* Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols<br>|
| Experimental: 1.6 g plant stanols and camelina oil<br>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 | Other: 1.6 g plant stanols and camelina oil<br>* Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil<br>|
| Experimental: 2 g plant stanols and camelina oil<br>A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks | Other: 2 g plant stanols and camelina oil<br>* Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil<br>|
| Placebo Comparator: Placebo<br>A placebo yoghurt drink, consumed with a meal daily for 4 weeks | Other: Placebo<br>* Lipid-lowering effect of Placebo Yoghurt Drink<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentual change in serum LDL-cholesterol | Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups | 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 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentual change in serum total cholesterol | Percentual change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups | 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 | 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 | 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 | 4 weeks | 
| Percentual change in serum triglycerides | Percentual change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups | 4 weeks | 
| Absolute change in serum triglycerides | Absolute change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups, mmol/l | 4 weeks |