Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

December 9, 2015 updated by: Raisio Group

The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations

The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI < 30 kg/m2
  • moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
  • serum triglycerides < 3 mmol/l.
  • normal liver, kidney and thyroid function
  • subjects must voluntarily sign the informed consent

Exclusion Criteria:

  • use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
  • lipid lowering medication
  • history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
  • pregnancy or lactation
  • alcohol abuse
  • subjects with intolerance to any ingredient of the test products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.6 g plant stanols
A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks
Other: 1.6 g plant stanols
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols
Experimental: 2 g plant stanols
A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks
Other: 2 g plant stanols
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols
Experimental: 1.6 g plant stanols and camelina oil
A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks
Other: 1.6 g plant stanols and camelina oil
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil
Experimental: 2 g plant stanols and camelina oil
A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks
Other: 2 g plant stanols and camelina oil
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil
Placebo Comparator: Placebo
A placebo yoghurt drink, consumed with a meal daily for 4 weeks
Other: Placebo
Lipid-lowering effect of Placebo Yoghurt Drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentual change in serum LDL-cholesterol
Time Frame: 4 weeks
Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups
4 weeks
Absolute change in serum LDL-cholesterol
Time Frame: 4 weeks
Absolute change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups, mmol/l
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentual change in serum total cholesterol
Time Frame: 4 weeks
Percentual change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups
4 weeks
Absolute change in serum total cholesterol
Time Frame: 4 weeks
Absolute change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups, mmol/l
4 weeks
Percentual change in serum non-HDL cholesterol
Time Frame: 4 weeks
Percentual change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups
4 weeks
Absolute change in serum non-HDL cholesterol
Time Frame: 4 weeks
Absolute change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l
4 weeks
Percentual change in serum triglycerides
Time Frame: 4 weeks
Percentual change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups
4 weeks
Absolute change in serum triglycerides
Time Frame: 4 weeks
Absolute change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups, mmol/l
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raisio Group

Collaborators

University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YD2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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