NCT02728583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

March 30, 2016

Last Update Submit

January 18, 2017

Conditions

Vascular DiseasesHypercholesterolemia

Keywords

Plant sterolsFish oilBlood lipids

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Secondary Outcomes (1)

  • Change in blood lipids

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

Other Outcomes (1)

  • Change in apolipoprotein concentrations

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

Study Arms (2)

Margarine enriched with plant sterols and fish oil

ACTIVE COMPARATOR

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 margarine

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo margarine

Interventions

Margarine enriched with plant sterols and fish oilDIETARY_SUPPLEMENT
Margarine enriched with plant sterols and fish oil
Placebo margarineDIETARY_SUPPLEMENT
Placebo margarine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Research Organisation

Berlin, Germany

Location

Related Publications (1)

  • Blom WAM, Koppenol WP, Hiemstra H, Stojakovic T, Scharnagl H, Trautwein EA. A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia. Eur J Nutr. 2019 Jun;58(4):1615-1624. doi: 10.1007/s00394-018-1706-1. Epub 2018 May 3.

    PMID: 29725824DERIVED

MeSH Terms

Conditions

Vascular DiseasesHypercholesterolemia

Interventions

PhytosterolsFish Oils

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological FactorsOils

Study Officials

  • Wieneke Koppenol, MSc

    Unilever R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 5, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)