The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids
NCT ID: NCT02728583
Last Updated: 2017-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
260 participants
INTERVENTIONAL
2016-04-30
2017-01-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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
Margarine enriched with plant sterols and fish oil
Placebo margarine
Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA
Placebo margarine
Interventions
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Margarine enriched with plant sterols and fish oil
Placebo margarine
Eligibility Criteria
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Inclusion Criteria
* Fasting LDL-C levels at screening: ≥ 3.4 and ≤ 4.9 mmol/L
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Unilever R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Wieneke Koppenol, MSc
Role: STUDY_DIRECTOR
Unilever R&D
Locations
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Charite Research Organisation
Berlin, , Germany
Countries
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References
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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.
Other Identifiers
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FDS-SCC-2150
Identifier Type: -
Identifier Source: org_study_id
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