CompletedInterventionalNot ApplicableUpdated Dec 3, 2021
Cholesterol-lowering Effects of Plant Stanol Ester | NCT02316808 | Trialant
CompletedInterventionalNot ApplicableUpdated Dec 23, 2014
Cholesterol-lowering Effects of Plant Stanol Ester
ClinicalTrials.gov ID
NCT02316808
Lead Sponsor
Raisio GroupINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
91Actual
Last Update Posted
Dec 23, 2014Estimated
Start Date
Aug 2011
Primary Completion Date
Dec 2011Actual
Completion Date
Dec 2011Actual
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.
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Plant stanol ester
placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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