NCT02728583

The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids

The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Diseases
• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Margarine enriched with plant sterols and fish oil
DIETARY_SUPPLEMENT	Placebo margarine

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-11-01
• Completion: 2017-01-01
• First posted: 2016-04-05
• Last updated: 2017-01-19

Locations

1 site across 1 country: Germany