Plasma Level of Various Omega-3 Lipids

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT03118999
• Lead Sponsor: Société des Produits Nestlé (SPN)

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).

Study Timeline

• Study Start: 2017-02-28
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Primary Completion: 2017-04-30
• Study Completion: 2017-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
AUC(0-24h) Plasma OM3	From Time 0 hour to Time 24 hours	Baseline-adjusted total plasma OM3 AUC(0-24h)

Secondary Outcome Measures

Name	Time	Method
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
Pharmacokinetic parameters (AUC) for EPA and DHA	From Time 0 hour to Time 24 hours	AUC(0-24h) Plasma EPA and DHA

Trial Locations

Locations (1)

Nestlé Research Center / Clinical Development Unit / Metabolic Unit; 🇨🇭 Lausanne 26, Vaud, Switzerland