Clinical trial NCT01313988: Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Mildly Elevated Cholesterol Levels
Keywords: dose-response study
blood lipid profile
plant sterols
fish oil
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 332
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in blood lipid profile
timeFrame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Secondary outcomes:
measure: Change in EPA/DHA in red blood cells
timeFrame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
measure: Change in metabolomic parameters
timeFrame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: KPL Good Food Practice AB
Study officials:
affiliation: KPL Good Food Practice AB
name: Johan Olsson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KPL Good Food Practice AB
name: Birgitta Sundberg, PhD
role: STUDY_DIRECTOR
affiliation: KPL Good Food Practice AB
name: Anneli Hallmin
role: STUDY_DIRECTOR
References:
citation: Ras RT, Demonty I, Zebregs YE, Quadt JF, Olsson J, Trautwein EA. Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women. J Nutr. 2014 Oct;144(10):1564-70. doi: 10.3945/jn.114.192229. Epub 2014 Aug 13.