Effect of Plant Stanol Esters on Blood Lipids

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00920894
• Date of registration: 12/06/2009
• Prospective Registration: No
• Primary sponsor: Clinical Life Sciences Ltd.
• Public title: Effect of Plant Stanol Esters on Blood Lipids
• Scientific title: The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration
• Date of first enrolment: January 2009
• Target sample size: 112
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00920894
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Finland

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Elevated Blood Lipids

Intervention(s)

Dietary Supplement: plant stanol ester

Primary Outcome(s)

plasma lipids [Time Frame: 10 weeks]

Secondary Outcome(s)

plasma lipoprotein lipids non-cholesterol sterols [Time Frame: 10 weeks]

Secondary ID(s)

Kainuu PlantStanol Ester Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors