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

• ClinicalTrials.gov Identifier: NCT02728583
• Recruitment Status: Completed
• First Posted: April 5, 2016
• Last Update Posted: January 19, 2017
• Sponsor: Unilever R&D
• Information provided by (Responsible Party): Unilever R&D

Tracking Information

• First Submitted Date: March 30, 2016
• First Posted Date: April 5, 2016
• Last Update Posted Date: January 19, 2017
• Study Start Date: April 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2016)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 30, 2016)

Change in blood lipids [ 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)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 30, 2016)

Change in apolipoprotein concentrations [ Time Frame: 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• Vascular Diseases
• Hypercholesterolemia

Intervention

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

Study Arms

• Active Comparator: Margarine enriched with plant sterols and fish oil
  Low-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil
  Intervention: Dietary Supplement: Margarine enriched with plant sterols and fish oil
• Placebo Comparator: Placebo margarine
  Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA
  Intervention: Dietary Supplement: Placebo margarine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 30, 2016): 260
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02728583
• Other Study ID Numbers: FDS-SCC-2150
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Unilever R&D
• Study Sponsor: Unilever R&D
• Collaborators: Not Provided

Investigators

• Study Director: Wieneke Koppenol, MSc; Unilever R&D

• PRS Account: Unilever R&D
• Verification Date: January 2017