The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids

January 18, 2017 updated by: Unilever R&D

The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids

The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.

The study also aims to investigate the effect of plant sterols and fish oil on fasting total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C) and non-HDL-C.

At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting TG concentrations.

The study also aims to investigate the effect of plant sterols and fish oil on fasting TC, LDL-C, HDL-C and non-HDL-C.

At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored. This exploratory objective will only be analyzed if a relevant treatment effect on fasting triglycerides concentrations is observed.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité Research Organisation

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fasting TG levels at screening: ≥ 1.40 and ≤ 5.60 mmol/L
  • Fasting LDL-C levels at screening: ≥ 3.4 and ≤ 4.9 mmol/L

Exclusion Criteria:

  • Recently (<6 months) diagnosed with cardiovascular event(s), revascularization or systemic inflammatory conditions.
  • Medical history which might impact study measurements, to be judged by the study physician
  • Use of over-the-counter and prescribed medication which may interfere with study measurements
  • Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening.
  • Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Margarine enriched with plant sterols and fish oil
Low-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil
Dietary supplement: Margarine enriched with plant sterols and fish oil
PLACEBO_COMPARATOR: Placebo margarine
Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA
Dietary supplement: Placebo margarine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TG concentrations
Time Frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)
At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood lipids
Time Frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)
At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in apolipoprotein concentrations
Time Frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Samples will only be analyzed if relevant treatment effects on TG are observed
At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Collaborators and Investigators

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

Sponsor

Unilever R&D

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

April 1, 2016

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

April 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDS-SCC-2150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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