LDL-cholesterol Level 130-159mg/dL
Conditions
Brief summary
The purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.
Detailed description
The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized, double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level 130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink without plant stanols) for 4-week. The investigators assessed blood cholesterol level.
Interventions
OTHERYoghurt drink containing plant stanol as esters
OTHERYoghurt drink without plant stanol as esters
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
• LDL-cholesterol level 130-159mg/dL (not taking cholesterol-lowering medications)
Exclusion criteria
* taking any medications (including anti-hypertensive, lipid lowering, anti-platelets, and anti-diabetic drugs) * history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease * history or presence of cancer * history of a psychiatric disorder and/or drug or alcohol abuse or dependency; * having a known intolerance to gluten or lactose * having a known allergy to any ingredient in the investigational product * women who are pregnant or desire to become pregnant during the study period or within 3 months of giving birth or breast feeding or within 3 months of cessation of breast feeding * having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline LDL-cholesterol at 4-week | at baseline and 4-week follow-up |
| Change from baseline total cholesterol at 4-week | at baseline and 4-week follow-up |
| Change from baseline non-HDL-cholesterol at 4-week | at baseline and 4-week follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline HDL-cholesterol at 4-week | at baseline and 4-week follow-up |
| Change from baseline triglyceride at 4-week | at baseline and 4-week follow-up |
| Change from baseline Apolipoprotein A1 at 4-week | at baseline and 4-week follow-up |
| Change from baseline Apolipoprotein B at 4-week | at baseline and 4-week follow-up |
Outcome results
None listed