Cholesterol-lowering Effects of Plant Stanol Ester
Not Applicable
Completed
- Conditions
- DyslipidemiasHypercholesterolemiaHyperlipidemias
- Registration Number
- NCT02316808
- Lead Sponsor
- Raisio Group
- Brief Summary
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
- total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL
- were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
- reachable by phone
- willing to declare written informed consent
- agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.
Exclusion Criteria
- Pregnant women
- obese
- diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL
- hyperthyroidism, a history of metabolic, endocrine and kidney disorders
- acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
- taking lipid-lowering medication or other medications likely to affect lipid metabolism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption. 4 weeks
- Secondary Outcome Measures
Name Time Method