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

Unilever

Status: Completed

Conditions: Hypercholesterolemia; Vascular Diseases

Treatments: Dietary Supplement: Margarine enriched with plant sterols and fish oil; Dietary Supplement: Placebo margarine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02728583

FDS-SCC-2150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

Margarine enriched with plant sterols and fish oil

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Margarine enriched with plant sterols and fish oil

Placebo margarine

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo margarine