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

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.

Full Title of Study: “The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: 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 Comparator: Placebo margarine
    • Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Unilever R&D
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wieneke Koppenol, MSc, Study Director, Unilever R&D

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