Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Not Applicable

Completed

• Conditions: Dyslipidemias; Hyperlipidemias; Hypercholesterolemia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Plant stanol ester

• 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

Arm && Interventions

Group	Intervention	Description
Placebo biscuit	Placebo	Biscuit without plant stanol ester
Plant stanol ester biscuit	Plant stanol ester	Biscuit with plant stanol esters

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