Healthy
Conditions
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENTOM3-FFA
Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design
DIETARY_SUPPLEMENTOM3-MAG
Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design
DIETARY_SUPPLEMENTOM3-EE
Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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: 1. Dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates (to the opinion of the investigator) 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-24h) Plasma OM3 | From Time 0 hour to Time 24 hours | Baseline-adjusted total plasma OM3 AUC(0-24h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters (AUC) for EPA and DHA | From Time 0 hour to Time 24 hours | AUC(0-24h) Plasma EPA and DHA |
| Pharmacokinetic parameters (Cmax) for EPA and DHA | From Time 0 hour to Time 24 hours | Cmax Plasma EPA and DHA |
| Pharmacokinetic parameters (Tmax) for EPA and DHA | From Time 0 hour to Time 24 hours | Tmax Plasma EPA and DHA |
Countries
Switzerland
Outcome results
None listed