Clinical trial NCT02728583: The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids
Official title: The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Hypercholesterolemia
Keywords: Plant sterols
Fish oil
Blood lipids
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Change in TG concentrations
timeFrame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Secondary outcomes:
measure: Change in blood lipids
timeFrame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Other outcomes:
measure: Change in apolipoprotein concentrations
timeFrame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Locations:
city: Berlin
country: Germany
facility: Charite Research Organisation
Study officials:
affiliation: Unilever R&D
name: Wieneke Koppenol, MSc
role: STUDY_DIRECTOR
References:
citation: 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.