Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

September 13, 2017 updated by: Raisio Group

Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids

The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Serum total cholesterol 5.2-8.5 mmol/l
  • Serum triglycerides < 3 mmol/l
  • Signed written informed consent

Exclusion Criteria:

  • Abnormal liver, kidney and thyroid function
  • Use of lipid lowering medication
  • Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
  • History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
  • Diagnosed type 1 or type 2 diabetes requiring medical treatment
  • History of recent temporal ischemic attack or malignant diseases (< 5 yrs)
  • Celiac disease, or allergy or intolerance to the ingredients of the test products
  • Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
  • Subjects with alcohol abuse (> 4 portion per day)
  • Pregnancy or planned pregnancy or lactating

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Plant stanol ester
Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).
Dietary supplement: Plant stanol ester
PLACEBO_COMPARATOR: Placebo
Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in serum LDL cholesterol
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change in serum LDL cholesterol (mmol/l)
Time Frame: 4 weeks
4 weeks
Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Raisio Group

Collaborators

Medfiles Ltd., Finland

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

January 1, 2016

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (ACTUAL)

September 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFRA004

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.

Clinical Trials on Dyslipidemias

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe