Lipid-lowering Effect of Plant Stanol Yogurt
The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
1 other identifier
interventional
70
1 country
1
Brief Summary
To determine the effect of investigational products on serum LDL cholesterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 18, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedJune 20, 2013
June 1, 2013
10 months
June 18, 2013
June 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in serum LDL cholesterol
4 weeks
Study Arms (2)
Yogurt that contains plant stanol esters
ACTIVE COMPARATORDietary Supplement: Yogurt that contains plant stanol esters
Placebo yogurt
PLACEBO COMPARATORDietary Supplement: Placebo yogurt
Interventions
Eligibility Criteria
You may qualify if:
- subjects must voluntarily sign the informed consent
- subjects must be male or female aged 20 to 70 years
- subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week)
You may not qualify if:
- subjects using lipid lowering medication
- subjects using ezetimibe
- subjects with bile acid sequestrant medication
- subjects with statin therapy
- subjects using other medication significantly influencing on lipid values
- subjects with diagnosis type 1 or type 2 diabetes
- severe obesity (BMI\>35.0 kg/m2)
- serum fasting triglycerides \> 4.0 mmol/l
- subjects with any hepatic or renal disorder according to medical history
- subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
- subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
- subjects who have history of temporal ischemic attack or stroke within six months prior to screening
- subjects who have a history of cancer or other malignant disease within the past five years
- subjects with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase\> 2 x upper limit, serum alkaline phosphatase\> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician
- subjects who are consuming more than 15 portions of alcohol / week
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Raisio Grouplead
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2013
First Posted
June 20, 2013
Study Start
March 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 20, 2013
Record last verified: 2013-06