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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728583
• Other study ID #: FDS-SCC-2150
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: January 18, 2017
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Vascular Diseases

Intervention

Dietary Supplement:
• Margarine enriched with plant sterols and fish oil

• Placebo margarine

Locations

Country	Name	City	State
Germany	Charite Research Organisation	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in apolipoprotein concentrations	Samples will only be analyzed if relevant treatment effects on TG are observed	At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Primary	Change in TG concentrations	Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)	At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Secondary	Change in blood lipids	Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)	At baseline (after 2 weeks run-in period) and after 4 weeks intervention