Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Not Applicable

Completed

• Conditions: Dyslipidemias; Hyperlipidemias; Hypercholesterolemia

• Registration Number: NCT02331043
• Lead Sponsor: Raisio Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2014-12-31
• Status Verified: 2015-01
• Study First Posted: 2015-01-05
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON); 🇹🇭 Phutthamonthon, Nakhon Pathom, Thailand

Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)

🇹🇭Phutthamonthon, Nakhon Pathom, Thailand