Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemias Hypercholesterolemia Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo biscuit

Biscuit without plant stanol ester

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Plant stanol ester biscuit

Biscuit with plant stanol esters

Group Type EXPERIMENTAL

Plant stanol ester

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Plant stanol ester

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes