Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester
1 other identifier
interventional
119
1 country
1
Brief Summary
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.
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 2013
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, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 31, 2014
CompletedFirst Posted
Study publicly available on registry
January 5, 2015
CompletedJanuary 8, 2015
January 1, 2015
5 months
December 31, 2014
January 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls
4 weeks
Secondary Outcomes (1)
Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal
4 weeks
Study Arms (2)
Placebo biscuit
PLACEBO COMPARATORBiscuit without plant stanol ester
Plant stanol ester biscuit
EXPERIMENTALBiscuit with plant stanol esters
Interventions
Eligibility Criteria
You may qualify if:
- mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
- fasting serum triglyceride levels below 3.0 mmol/l
- normal liver, kidney and thyroid function
- no lipid lowering medication
- no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases
You may not qualify if:
- alcohol abuse (\> 4 portion/per day)
- pregnancy
- use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Raisio Grouplead
- Mahidol Universitycollaborator
Study Sites (1)
Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)
Phutthamonthon, Changwat Nakhon Pathom, 73170, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wantanee Kriengsinyos, PhD
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2014
First Posted
January 5, 2015
Study Start
March 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
January 8, 2015
Record last verified: 2015-01