Plasma Level of Various Omega-3 Lipids | NCT03118999

Studies
Plasma Level of Various Omega-3 Lipids

NCT03118999

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Sep 20, 2018Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

OM3-FFA
OM3-MAG
OM3-EE

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2017Actual

Primary Completion Date

Apr 30, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

Mar 30, 2017

First Submission Date that Met QC Criteria

Apr 13, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2018

Last Update Posted Date

Sep 20, 2018Actual

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OM3-FFA	Experimental	Omega3 linked to free fatty acids	Dietary Supplement: OM3-MAG Dietary Supplement: OM3-EE
OM3 -MAG	Experimental	Omega3 linked to Monoacylglycerol	Dietary Supplement: OM3-FFA Dietary Supplement: OM3-EE
OM3-EE	Experimental	Omega3 linked to ethylester	Dietary Supplement: OM3-FFA Dietary Supplement: OM3-MAG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OM3-FFA	Dietary Supplement	Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design	OM3 -MAG OM3-EE

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided