Status:
COMPLETED
Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester
Lead Sponsor:
Raisio Group
Collaborating Sponsors:
Oy Medfiles Ltd
Conditions:
Hypercholesterolemia
Hyperlipidemias
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects wi...
Eligibility Criteria
Inclusion
- Serum total cholesterol 5.2-8.5 mmol/l
- Serum triglycerides \< 3 mmol/l
- Signed written informed consent
Exclusion
- Abnormal liver, kidney and thyroid function
- Use of lipid lowering medication
- Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
- History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
- Diagnosed type 1 or type 2 diabetes requiring medical treatment
- History of recent temporal ischemic attack or malignant diseases (\< 5 yrs)
- Celiac disease, or allergy or intolerance to the ingredients of the test products
- Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
- Subjects with alcohol abuse (\> 4 portion per day)
- Pregnancy or planned pregnancy or lactating
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03284918
Start Date
January 1 2016
End Date
September 1 2016
Last Update
September 15 2017
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