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

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ClinicalTrials.gov Identifier: NCT02728583
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Study Description
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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.


Condition or disease Intervention/treatment Phase
Vascular Diseases Hypercholesterolemia Dietary Supplement: Margarine enriched with plant sterols and fish oil Dietary Supplement: Placebo margarine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids
Study Start Date : April 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
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
 Dietary Supplement: Margarine enriched with plant sterols and fish oil
Placebo Comparator: Placebo margarine
Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA
 Dietary Supplement: Placebo margarine


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728583


Locations
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Germany
Charite Research Organisation
Berlin, Germany
Sponsors and Collaborators
Unilever R&D
Investigators
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Study Director: Wieneke Koppenol, MSc Unilever R&D
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT02728583    
Other Study ID Numbers: FDS-SCC-2150
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Unilever R&D:
Plant sterols
Fish oil
Blood lipids
Additional relevant MeSH terms:
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Vascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases