Healthy Diet Clinical Trial
Official title:
Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)
Verified date | September 2021 |
Source | University of Oslo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control). Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - BMI 20-35kg/m2 - opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period. Exclusion Criteria: - Chronic disease (liver/kidney/metabolism) - Alcohol overconsumption (>40g/day) - Diabetes and high fasting blood glucose - Pregnant/ breastfeeding or planning pregnancy during the study period - High fish intake (>3 meals/week). - Blood donation during the study period - Difficulty following the study protocol. - Smoking/snuffing - Regularly use of anti-inflammatory drugs - Regularly use of omega-3 supplements /cod liver oil. |
Country | Name | City | State |
---|---|---|---|
Norway | University of Oslo | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Oslo | Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EPA and DHA in plasma | EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit) | 4 weeks intervention | |
Primary | EPA and DHA in red blood cells | EPA and DHA concentration and omega 3 index (EPA+DHA/total fatty acids) in red blood cells measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit) | 4 weeks | |
Secondary | Lipid profile- Triglycerides | Plasma levels of triglycerides measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit) | 4 weeks | |
Secondary | Lipid profile- Cholesterol | Plasma levels of cholesterol (total cholesterol, LDL-cholesterol and HDL-cholesterol) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit) | 4 weeks | |
Secondary | Lipid profile- Apolipoproteins | Plasma levels of apolipoproteins (apoB and apoA) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit) | 4 weeks | |
Secondary | Lipid profile- Lipoproteins | Plasma levels of Lp(a) and lipoprotein subclasses measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit) | 4 weeks | |
Secondary | Inflammatory markers | The concentration of circulating levels of inflammatory markers measured at baseline and after 4 weeks intervention ( and as a "control measurement" at screening) | 4 weeks | |
Secondary | Gene expression | Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention | 4 weeks | |
Secondary | Pain sensitivity | Measured by cold pressure tests at baseline and after 4 week of intervention ( and as a control measurement at screening) | 4 weeks | |
Secondary | Resolvins | Blood levels of resolvins (omega- 3 derivates) concentrations measured at baseline and after 4 week of intervention ( and as a control measurement at screening) | 4 weeks | |
Secondary | Metabolome | Changes in metabolome measured at baseline and after 4 week of intervention | 4 weeks |
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