NCT03284918CompletedNot Applicable
Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids
Raisio Group0 sites71 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Primary Endpoint
- Percentage change in serum LDL cholesterol
Study Overview
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 with mild to moderate hypercholesterolemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Serum total cholesterol 5.2-8.5 mmol/l
- •Serum triglycerides < 3 mmol/l
- •Signed written informed consent
Exclusion Criteria
- •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
Arms & Interventions
Plant stanol ester
Experimental
Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).
Intervention: Plant stanol ester (Dietary Supplement)
Placebo
Placebo Comparator
Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Percentage change in serum LDL cholesterol
Time Frame: 4 weeks
Secondary Outcomes
- Absolute change in serum LDL cholesterol (mmol/l)(4 weeks)
- Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides(4 weeks)
Investigators
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