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

Efficacy Study on the Lipid-lowering Effect of a Spread Enriched With the Recommended Dose of Plant Sterols and 3 Different Doses of Fatty Acids From Fish Oil

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.

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