The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Diseases
- Sponsor
- Unilever R&D
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Change in TG concentrations
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Change in blood lipids(At baseline (after 2 weeks run-in period) and after 4 weeks intervention)