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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

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date January 19, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2016)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids
Official Title  ICMJE The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Vascular Diseases
  • Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Margarine enriched with plant sterols and fish oil
  • Dietary Supplement: Placebo margarine
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Dietary Supplement: Placebo margarine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2016)
260
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728583
Other Study ID Numbers  ICMJE FDS-SCC-2150
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Unilever R&D
Study Sponsor  ICMJE Unilever R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wieneke Koppenol, MSc Unilever R&D
PRS Account Unilever R&D
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP