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

Not Applicable

Completed

• Conditions: Mildly Elevated Cholesterol Levels; Healthy
• Interventions: Dietary Supplement: Plant sterols and fish oil; Dietary Supplement: Placebo; Dietary Supplement: Plant sterols

• 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

Arm && Interventions

Group	Intervention	Description
Dose 1	Plant sterols and fish oil	Spread that contains plant sterols and fish oil
Dose 2	Plant sterols and fish oil	Spread that contains plant sterols and fish oil
Dose 3	Plant sterols and fish oil	Spread that contains plant sterols and fish oil
Placebo	Placebo	Placebo spread
Control	Plant sterols	Spread that contains plant sterols

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