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

Primary Purpose

Vascular Diseases, Hypercholesterolemia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Margarine enriched with plant sterols and fish oil

Placebo margarine

About this trial

This is an interventional basic science trial for Vascular Diseases focused on measuring Plant sterols, Fish oil, Blood lipids

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Charite Research Organisation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Margarine enriched with plant sterols and fish oil

Placebo margarine

Arm Description

Low-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil

Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA

Outcomes

Primary Outcome Measures

Change in TG concentrations

Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)

Secondary Outcome Measures

Change in blood lipids

Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)

Full Information

NCT ID

NCT02728583

First Posted

March 30, 2016

Last Updated

January 18, 2017

Sponsor

Unilever R&D

1. Study Identification

Unique Protocol Identification Number

NCT02728583

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unilever R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Diseases, Hypercholesterolemia

Keywords

Plant sterols, Fish oil, Blood lipids

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Margarine enriched with plant sterols and fish oil

Arm Type

Active Comparator

Arm Description

Low-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil

Arm Title

Placebo margarine

Arm Type

Placebo Comparator

Arm Description

Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA

Intervention Type

Dietary Supplement

Intervention Name(s)

Margarine enriched with plant sterols and fish oil

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo margarine

Primary Outcome Measure Information:

Title

Change in TG concentrations

Description

Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)

Time Frame

At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Secondary Outcome Measure Information:

Title

Change in blood lipids

Description

Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)

Time Frame

At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Other Pre-specified Outcome Measures:

Title

Change in apolipoprotein concentrations

Description

Samples will only be analyzed if relevant treatment effects on TG are observed

Time Frame

At baseline (after 2 weeks run-in period) and after 4 weeks intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wieneke Koppenol, MSc

Organizational Affiliation

Unilever R&D

Official's Role

Study Director

Facility Information:

Facility Name

Charite Research Organisation

City

Berlin

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29725824

Citation

Blom WAM, Koppenol WP, Hiemstra H, Stojakovic T, Scharnagl H, Trautwein EA. A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia. Eur J Nutr. 2019 Jun;58(4):1615-1624. doi: 10.1007/s00394-018-1706-1. Epub 2018 May 3.

Results Reference

derived

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

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