Nestlé Research Center / Clinical Development Unit / Metabolic Unit
Lausanne, Canton of Vaud, 1000, Switzerland
NCT Number: NCT03118999
The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Lausanne, Canton of Vaud, 1000, Switzerland
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc. ii. Known hypertriglyceridemia (on anamnesis) iii. Known Type2 Diabetes Mellitus
Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design
Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design
Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design
Time frame: From Time 0 hour to Time 24 hours
Baseline-adjusted total plasma OM3 AUC(0-24h)
Time frame: From Time 0 hour to Time 24 hours
AUC(0-24h) Plasma EPA and DHA
Time frame: From Time 0 hour to Time 24 hours
Cmax Plasma EPA and DHA
Time frame: From Time 0 hour to Time 24 hours
Tmax Plasma EPA and DHA
Société des Produits Nestlé (SPN)
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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