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Completed

NCT Number: NCT02728583

The Effects of a Spread With Added Plant Sterols and 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite Research Organisation

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Margarine enriched with plant sterols and fish oil

Dietary Supplement

Placebo margarine

Dietary Supplement

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 5, 2016
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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