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

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Vascular Diseases
• Interventions: Dietary Supplement: Margarine enriched with plant sterols and fish oil; Dietary Supplement: Placebo margarine

• Registration Number: NCT02728583
• Lead Sponsor: Unilever R&D

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.

Study Timeline

• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-03-30
• Study Start: 2016-04
• Study First Posted: 2016-04-05
• Primary Completion: 2016-11
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Margarine enriched with plant sterols and fish oil	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
Placebo margarine	Placebo margarine	Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA

Primary Outcome Measures

Name	Time	Method
Change in TG concentrations	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)

Secondary Outcome Measures

Name	Time	Method
Change in blood lipids	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)

Trial Locations

Locations (1)

Charite Research Organisation; 🇩🇪 Berlin, Germany