Healthy, Mildly Elevated Cholesterol Levels
Conditions
Keywords
dose-response study, blood lipid profile, plant sterols, fish oil
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.
Interventions
DIETARY_SUPPLEMENTPlant sterols and fish oil
4 weeks intervention, 3 times daily
DIETARY_SUPPLEMENTPlant sterols
4 weeks intervention, 3 times daily
DIETARY_SUPPLEMENTPlacebo
4 weeks, 3 times daily
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed