Effect of Plant Stanol Esters on Blood Lipids (NCT00920894)

Study summary

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

Read the detailed description

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 studied

Elevated Blood Lipids

In context

Lead sponsor

Clinical Life Sciences Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 112 participants (estimated)

Study arms

Experimental
yoghurt type minidrink containing plant stanol ester
Dietary Supplement: plant stanol ester
Placebo comparator
yoghurt type minidrink without plant stanol ester
Dietary Supplement: plant stanol ester

Interventions

Dietary supplementplant stanol ester
the effect of plant stanol esters on plasma lipids

What researchers measure

Primary outcomes

plasma lipids
Time frame: 10 weeks

Secondary outcomes

plasma lipoprotein lipids non-cholesterol sterols
Time frame: 10 weeks

Study locations

1 site

Clinical Life Sciences Ltd
Vuokatti, 88610, Finland

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00920894
Lead sponsor: Clinical Life Sciences Ltd.
First posted: Jun 15, 2009
Start date: Jan 2009
Primary completion: Jun 2009
Completion: Nov 2009
Last update: Nov 5, 2009

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Effect of Plant Stanol Esters on Blood Lipids