Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Raisio Group119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

119

Conditions

Dyslipidemias Hypercholesterolemia Hyperlipidemias

Interventions

Plant stanol esterDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Phutthamonthon, Changwat Nakhon Pathom, Thailand

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Secondary Outcomes

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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