Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlant stanol ester
Smoothie that contains plant stanol ester
DIETARY_SUPPLEMENTplacebo
Smoothie that contains placebo
Sponsors
Indonesia University
Raisio Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption. | 4 weeks |
Outcome results
None listed