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

Unilever R&D260 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

260

Conditions

Vascular Diseases Hypercholesterolemia

Interventions

Margarine enriched with plant sterols and fish oilDIETARY_SUPPLEMENT

Placebo margarineDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Charite Research Organisation

Berlin, Germany

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

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)

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

Data from ClinicalTrials.gov

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