Effect of Plant Stanol Esters on Blood Lipids

NCT ID: NCT00920894

Last Updated: 2009-11-05

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-11-30

Brief Summary

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This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

Detailed Description

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The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.

This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Conditions

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Elevated Blood Lipids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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yoghurt type minidrink containing plant stanol ester

Group Type EXPERIMENTAL

plant stanol ester

Intervention Type DIETARY_SUPPLEMENT

the effect of plant stanol esters on plasma lipids

yoghurt type minidrink without plant stanol ester

Group Type PLACEBO_COMPARATOR

plant stanol ester

Intervention Type DIETARY_SUPPLEMENT

the effect of plant stanol esters on plasma lipids

Interventions

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plant stanol ester

the effect of plant stanol esters on plasma lipids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Elevated blood lipids
* Body Mass Index \< 35 kg/m2
* Stable body weight

Exclusion Criteria

* Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
* Severe obesity
* Hyperglycemia
* Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
* Hepatic, kidney or thyroid disease or disorder
* Pregnancy or breast feeding
* Severe intolerance or allergy to any ingredient of test product
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Life Sciences Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Clinical Life Sciences Ltd

Locations

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Clinical Life Sciences Ltd

Vuokatti, , Finland

Site Status

Countries

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Finland

Other Identifiers

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Kainuu PlantStanol Ester Study

Identifier Type: -

Identifier Source: org_study_id

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