NCT03118999

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

March 30, 2017

Last Update Submit

September 19, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • AUC(0-24h) Plasma OM3

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

    From Time 0 hour to Time 24 hours

Secondary Outcomes (3)

  • Pharmacokinetic parameters (AUC) for EPA and DHA

    From Time 0 hour to Time 24 hours

  • Pharmacokinetic parameters (Cmax) for EPA and DHA

    From Time 0 hour to Time 24 hours

  • Pharmacokinetic parameters (Tmax) for EPA and DHA

    From Time 0 hour to Time 24 hours

Study Arms (3)

OM3-FFA

EXPERIMENTAL

Omega3 linked to free fatty acids

Dietary Supplement: OM3-MAGDietary Supplement: OM3-EE

OM3 -MAG

EXPERIMENTAL

Omega3 linked to Monoacylglycerol

Dietary Supplement: OM3-FFADietary Supplement: OM3-EE

OM3-EE

EXPERIMENTAL

Omega3 linked to ethylester

Dietary Supplement: OM3-FFADietary Supplement: OM3-MAG

Interventions

OM3-FFADIETARY_SUPPLEMENT

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

OM3 -MAGOM3-EE
OM3-MAGDIETARY_SUPPLEMENT

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

OM3-EEOM3-FFA
OM3-EEDIETARY_SUPPLEMENT

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

OM3 -MAGOM3-FFA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nestlé Research Center / Clinical Development Unit / Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Study Officials

  • Bernard Cuénoud

    Nestec Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 food supplements containing omega3 (one test period per product).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 18, 2017

Study Start

February 28, 2017

Primary Completion

April 30, 2017

Study Completion

August 31, 2017

Last Updated

September 20, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)