Skip to main content
OpenTrials
Completed

NCT Number: NCT03118999

Plasma Level of Various Omega-3 Lipids

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nestlé Research Center / Clinical Development Unit / Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OM3-FFA

Dietary Supplement

Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design

OM3-MAG

Dietary Supplement

Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design

OM3-EE

Dietary Supplement

Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design

Primary outcomes

  1. AUC(0-24h) Plasma OM3

    Time frame: From Time 0 hour to Time 24 hours

    Baseline-adjusted total plasma OM3 AUC(0-24h)

Secondary outcomes

  1. Pharmacokinetic parameters (AUC) for EPA and DHA

    Time frame: From Time 0 hour to Time 24 hours

    AUC(0-24h) Plasma EPA and DHA

  2. Pharmacokinetic parameters (Cmax) for EPA and DHA

    Time frame: From Time 0 hour to Time 24 hours

    Cmax Plasma EPA and DHA

  3. Pharmacokinetic parameters (Tmax) for EPA and DHA

    Time frame: From Time 0 hour to Time 24 hours

    Tmax Plasma EPA and DHA

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2017
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.