Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
Conditions
Brief summary
Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.
Interventions
DIETARY_SUPPLEMENTSupplement product with plant stanol ester
2 grams plant stanols consumed with a meal daily for 3 to 4 weeks
Sponsors
Clinical Research Institute HUCH Ltd
Raisio Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male and female over 18 years old * serum LDL cholesterol \> 3.0 mmol/L * BMI \< 35 * subjects must voluntarily sign the informed consent
Exclusion criteria
* subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy) * subjects with any hepatic or renal disorder according to medical history * subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening * subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening * subjects who have history of temporal ischemic attack or stroke within six months prior to screening * subjects who have a history of cancer or other malignant disease within the past five years * subjects who are consuming more than 15 portions of alcohol / week * subjects who are pregnant or lactating * subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention * subjects with intolerance to any ingredient of the test product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportional change in serum LDL cholesterol | 3 to 4 weeks | Proportional change \[end of intervention - start of intervention\] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportional change in total cholesterol | 3 to 4 weeks | Proportional change \[end of intervention - start of intervention\] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. |
| Proportional change in non-HDL-cholesterol | 3 to 4 weeks | Proportional change \[end of intervention - start of intervention\] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. |
| Proportional change in serum triglycerides | 3 to 4 weeks | Proportional change \[end of intervention - start of intervention\] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. |
| Proportional change in lipids in all study participants | 3 to 4 weeks | Proportional change \[end of intervention - start of intervention\] in serum lipids in all study participants (ITT analysis) |
| Proportional change in lipids in subjects without metabolic derangements | 3 to 4 weeks | Proportional change \[end of intervention - start of intervention\] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome) |
Outcome results
None listed