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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: OM3-MAG; Dietary supplement: OM3-EE; Dietary supplement: OM3-FFA

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne 26, Vaud, Switzerland, 1000
      • Nestlé Research Center / Clinical Development Unit / Metabolic Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OM3-FFA; Omega3 linked to free fatty acids	Dietary supplement: OM3-MAG; Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design; Dietary supplement: OM3-EE; Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design
Experimental: OM3 -MAG; Omega3 linked to Monoacylglycerol	Dietary supplement: OM3-EE; Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design; Dietary supplement: OM3-FFA; Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design
Experimental: OM3-EE; Omega3 linked to ethylester	Dietary supplement: OM3-MAG; Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design; Dietary supplement: OM3-FFA; Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-24h) Plasma OM3	Baseline-adjusted total plasma OM3 AUC(0-24h)	From Time 0 hour to Time 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters (AUC) for EPA and DHA	AUC(0-24h) Plasma EPA and DHA	From Time 0 hour to Time 24 hours
Pharmacokinetic parameters (Cmax) for EPA and DHA	Cmax Plasma EPA and DHA	From Time 0 hour to Time 24 hours
Pharmacokinetic parameters (Tmax) for EPA and DHA	Tmax Plasma EPA and DHA	From Time 0 hour to Time 24 hours

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Director: Bernard Cuénoud, Nestec Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16.18.BIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No