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| Name | Class |
|---|---|
| Throne-Holst Foundation for Nutrition Research | UNKNOWN |
| Horizon 2020 - European Commission | OTHER |
| GC Rieber VivoMega AS | UNKNOWN |
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The aim of this project is to elucidate how repeated exposure with omega-3 fatty acid supplementation for 6 weeks affect mean and individual fasting lipids and inflammatory responses and postprandial TG after a high fat meal with butter (50 g fat) in healthy subjects.
The investigators aim to perform a randomized controlled crossover trial where each participant will act as his or her own control. Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement, dose of 2.3 g Eicosapentaenoic acid fatty acids (EPA) + Docosahexaenoic acid fatty acids (DHA) /day) for 6 weeks or a high-oleic sunflower oil (HOSO) containing no omega-3 fatty acids, as control followed by a wash-out period of minimum 12 weeks, before the treatment is changed for 6 weeks. Before and after each intervention period we will take fasting blood samples and collect spot morning urine. At home, the participant will perform a voluntary postprandial meal test with 61 g butter (containing 50 g fat), use DBS to collect fasting (0 h) 2, 4, 6, and 8 h blood samples after intake of the meal to measure TG which has been validated previously.
The investigators will use first part of the trial to define fasting and postprandial TG responders and non-responders. The investigators will also monitor at home the postprandial TG response to HOSO to see the participants' postprandial response to a control oil without omega-3 fatty acids. After a 12 week wash-out period, we will then repeat the fish oil intervention period once more for all in order to see if those we defined as responders continue to be defined in the same category in the repeated fish oil intervention (adaptive design). The investigators will collect exposure data, including dietary intake, physical activity, and clinical data such as BMI, body composition (such as fat mass, visceral fat, fat free mass), blood pressure, lipids and glucose and specific single nucleotide polymorphism (SNPs) to understand the impact of these factors on the individual postprandial TG response. In addition, the investigators will collect feces samples before taken before each meal test day for gut microbiota analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil (the omega-3 fatty acid supplement) | Experimental | Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement) for 6 weeks. Followed by a wash-out period of a minimum of 12 weeks before the treatment is changed. Once the classical Randomized Controlled Trial (RCT) has finished, all the participants will repeat the fish oil intervention period (adaptive design) to determine if those the investigators defined as responders continue to be defined in the same category. |
|
| High-oleic sunflower oil (HOSO) containing no omega-3 fatty acids | Placebo Comparator | Participants will be randomized to either start to receive high-oleic sunflower oil (HOSO) for 6 weeks. Followed by a wash-out period of minimum 12 weeks, before the treatment is changed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega- 3 | Dietary Supplement | In the fish oil supplement period, the participants will receive concentrated fish oil which is equal to in total 2.3 g EPA+DHA per day during 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting TG | Baseline levels of circulating triglycerides | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial TG | At home, the participant will perform a voluntary postprandial meal test with 61 g butter (containing 50 g fat), use DBS to collect fasting(0 h) 2, 4, 6, and 8 h blood samples after intake of the meal | up to 6 weeks |
| Fasting cholesterol, free fatty acids (FFA), LDL cholesterol, high-density lipoprotein (HDL) cholesterol, Apo A1, Apo B, Apo B-48 and Apo C-III, and lipoprotein subclasses, glucose and insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oslo | Oslo | Norway |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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Start with control oil (HOSO) or start with fish oil, and then change after 12 weeks of wash out.
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The principal investigator will have access to the randomization code containing the order of the oils (starting with HOSO or starting with fish oil), which is generated by an external statistician. The PI will make sure that the identical boxes with capsules (both HOSO and fish oil) will be marked only with Identification (ID) number and period number (cross over 1 and 2). The participant, the care provider and the outcomes assessor will not know the randomization code before after the data of the primary outcome has been analyzed.
| HOSO | Dietary Supplement | In the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks. |
|
measure fasting levels -compare fasting levels before and after intake of omega-3 or HOSO |
| up to 6 weeks |
| Fasting plasma cytokines, acute phase proteins and soluble adhesion molecules | measure fasting levels of all inflammatory markers before and after intake of omega-3 or HOSO | up to 6 weeks |
| Fasting whole genome Peripheral Blood Mononuclear Cells (PBMC) transcriptome (mRNA and miRNA) | fasting levels before and after intake of omega-3 or HOSO | up to 6 weeks |
| Fasting epigenome in PBMCs | fasting levels before and after intake of omega-3 or HOSO | up to 6 weeks |
| Fasting targeted and non-targeted metabolic profiling in plasma | fasting levels before and after intake of omega-3 or HOSO | up to 6 weeks |
| Targeted and untargeted metabolomics of spot urine to measure dietary intake biomarkers | Measure food intake metabolites in spot urine | up to 6 weeks |
| SNPs in whole blood | measure specific SNPs related to omega-3 intake and TG response | Measured once at baseline |
| Composition of the gut microbiome (both metabolites and bacteria composition) | measure metabolites in blood and feces and bacteria composition in feces | up to 6 weeks |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |