Hypercholesterolemia, Vascular Diseases
Conditions
Keywords
Plant sterols, Fish oil, 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.
Interventions
DIETARY_SUPPLEMENTMargarine enriched with plant sterols and fish oil
DIETARY_SUPPLEMENTPlacebo margarine
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TG concentrations | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in blood lipids | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in apolipoprotein concentrations | 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 |
Countries
Germany
Outcome results
None listed