Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil

Not Applicable

Completed

• Conditions: Mildly Elevated Cholesterol Levels; Healthy

• Registration Number: NCT01313988
• Lead Sponsor: Unilever R&D

Brief Summary

Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-14
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-02-05
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• Apparently healthy men and women
• Age ≥ 25 and ≤ 75 years old
• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
• Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
• 10-year CVD risk equal or lower than 10% according to "SCORE"
• Blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges
• Informed consent and biobank consent signed
• Willing to comply to study protocol during study
• Agreeing to be informed about medically relevant personal test-results by a physician
• Not smoking
• Accessible veins on the forearm
• Habitually consuming spreads

Exclusion Criteria

• Pregnant or having the wish to become pregnant, or lactating
• Use of prescribed medication which may interfere with study measurements
• Use of antibiotics in the 3 months before screening or during the study
• Use of any medically- or self-prescribed diet with the purpose to reduce weight
• Intolerance for gluten or lactose
• Reported food allergy
• Having bleeding disorders
• Recent blood donation
• Excessive alcohol consumption
• Strenuous exercise
• Reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs
• Recent participation in another nutritional or medical trial
• Participation in night shift work

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in blood lipid profile	At baseline (after 4 weeks run-in period) and after 4 weeks intervention	Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides

Secondary Outcome Measures

Name	Time	Method
Change in EPA/DHA in red blood cells	At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Change in metabolomic parameters	At baseline (after 4 weeks run-in period) and after 4 weeks intervention	For exploratory purposes

Trial Locations

Locations (1)

KPL Good Food Practice AB; 🇸🇪 Uppsala, Sweden