Plasma Level of Various Omega-3 Lipids

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers

Detailed Description
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This is a single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 products (one test period per product). The three different test periods will be separated by a washout period of at least 6 days (up to 21 days).

Official Title
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Plasma Level of Various Omega-3 Lipids

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: OM3-FFA
* Dietary Supplement: OM3-MAG
* Dietary Supplement: OM3-EE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 65 years old BMI in the normal and overweight range (18.5 to 29.9 kg/m2) Able to understand and to sign written informed consent prior to trial entry Informed consent signed Exclusion Criteria: Food allergy Documented clinically relevant disease impacting the endpoints of the study or the safety of the subject, as determined by the medical (screening) visit: i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc. ii. Known hypertriglyceridemia (on anamnesis) iii. Known Type2 Diabetes Mellitus Under medication that may impact: Dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates (to the opinion of the investigator) Coagulation (blood thinning medications, anticoagulants). Indeed, OM3 have been shown to possibly exert some bleeding by themselves that may increase the bleeding effects of aspirin and anticoagulants Having taken omega-3, EPA/DHA, fish oil supplementation for more than two consecutive weeks during the last 2 months Having given blood within the last month, or willing to make a blood donation until one month following the end of the study Subjects not willing and/or not able to comply with scheduled visits and with the requirements of the study protocol, including trial products consumption and food restriction Pregnancy (on anamnesis) Any direct collaborator of the study leader (Dr. Maurice Beaumont) Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 food supplements containing omega3 (one test period per product).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OM3-FFA<br>Omega3 linked to free fatty acids | Dietary Supplement: OM3-MAG<br>* Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design<br>Dietary Supplement: OM3-EE<br>* Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design<br>|
| Experimental: OM3 -MAG<br>Omega3 linked to Monoacylglycerol | Dietary Supplement: OM3-FFA<br>* Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design<br>Dietary Supplement: OM3-EE<br>* Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design<br>|
| Experimental: OM3-EE<br>Omega3 linked to ethylester | Dietary Supplement: OM3-FFA<br>* Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design<br>Dietary Supplement: OM3-MAG<br>* Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-24h) Plasma OM3 | Baseline-adjusted total plasma OM3 AUC(0-24h) | From Time 0 hour to Time 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (AUC) for EPA and DHA | AUC(0-24h) Plasma EPA and DHA | From Time 0 hour to Time 24 hours | 
| Pharmacokinetic parameters (Cmax) for EPA and DHA | Cmax Plasma EPA and DHA | From Time 0 hour to Time 24 hours | 
| Pharmacokinetic parameters (Tmax) for EPA and DHA | Tmax Plasma EPA and DHA | From Time 0 hour to Time 24 hours |