Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
Conditions
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
Interventions
OTHER1.6 g plant stanols
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols
OTHER2 g plant stanols
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols
OTHER1.6 g plant stanols and camelina oil
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil
OTHER2 g plant stanols and camelina oil
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil
OTHERPlacebo
Lipid-lowering effect of Placebo Yoghurt Drink
Sponsors
University of Turku
Raisio Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 total cholesterol | 4 weeks | Absolute change \[end of intervention - start of intervention\] in serum total cholesterol between experimental and placebo groups, mmol/l |
Outcome results
None listed