Clinical trial NCT03118999: Plasma Level of Various Omega-3 Lipids
Official title: Plasma Level of Various Omega-3 Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: AUC(0-24h) Plasma OM3
timeFrame: From Time 0 hour to Time 24 hours
Secondary outcomes:
measure: Pharmacokinetic parameters (AUC) for EPA and DHA
timeFrame: From Time 0 hour to Time 24 hours
measure: Pharmacokinetic parameters (Cmax) for EPA and DHA
timeFrame: From Time 0 hour to Time 24 hours
measure: Pharmacokinetic parameters (Tmax) for EPA and DHA
timeFrame: From Time 0 hour to Time 24 hours
Other outcomes:
Locations:
city: Lausanne 26
country: Switzerland
facility: Nestlé Research Center / Clinical Development Unit / Metabolic Unit
state: Vaud
Study officials:
affiliation: Nestec Ltd.
name: Bernard Cuénoud
role: STUDY_DIRECTOR
References: