Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Hypercholesterolemia Clinical Trial

Official title:

Serum Cholesterol Reduction Efficacy of Biscuit With Added Plant Stanol Ester

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331043
• Other study ID #: CL 2012_034
• Status: Completed
• Phase: N/A
• First received: December 31, 2014
• Last updated: January 7, 2015
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: January 2015
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Plant stanol ester

• Placebo

Locations

Country	Name	City	State
Thailand	Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)	Phutthamonthon	Nakhon Pathom

Sponsors (2)

Lead Sponsor	Collaborator
Raisio Group	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls		4 weeks	No
Secondary	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	No