NCT02957188

Brief Summary

The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA) and 13C-arachidonic acid (AA) in young and older participants

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

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

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

October 24, 2016

Last Update Submit

November 2, 2016

Conditions

Keywords

Eicosapentaenoic acidArachidonic acidMetabolismHealthy aging

Outcome Measures

Primary Outcomes (1)

  • Kinetics of 13C-EPA and 13C-AA

    Plasma incorporation of 13C-EPA or 13C-AA was measured from the area under the curve in young and older participants over 28 days post-dose

Study Arms (2)

Young

Six young (18-30 yrs old) healthy participants were recruited. The study had three blocks of one month: 13C-EPA follow-up, wash-out and 13C-AA follow-up. Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA.

Other: 13C eicosapentaenoic acid and 13C arachidonic acid

Elderly

Six older (≥ 70 yrs old) healthy participants were recruited. The study had three blocks of one month: 13C-EPA follow-up, wash-out and 13C-AA follow-up. Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA.

Other: 13C eicosapentaenoic acid and 13C arachidonic acid

Interventions

Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA.

ElderlyYoung

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Young and elderly healthy participants

You may qualify if:

  • six young (18-30 y old) and six older (≥ 70 y old)
  • healthy non medicated participants.

You may not qualify if:

  • Tobacco,
  • malnutrition (assessed from blood albumin, haemoglobin and lipids), -
  • participants taking an EPA+DHA supplements or consuming more than 2 fish meals per week,
  • severe gastro-intestinal problems,
  • medication for diabetes,
  • thyroid disease,
  • renal failure,
  • cancer,
  • psychiatric difficulties or depression,
  • cardiovascular disease,
  • glucose intolerance (\>8 mmol/L in fasted samples)
  • chronic immune condition or inflammation (CRP \> 10 mg/l, white cell count),
  • recent major surgery or cardiac event,
  • dementia,
  • ongoing or past severe drug or alcohol abuse,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Leveille P, Chouinard-Watkins R, Windust A, Lawrence P, Cunnane SC, Brenna JT, Plourde M. Metabolism of uniformly labeled 13C-eicosapentaenoic acid and 13C-arachidonic acid in young and old men. Am J Clin Nutr. 2017 Aug;106(2):467-474. doi: 10.3945/ajcn.117.154708. Epub 2017 Jun 28.

Biospecimen

Retention: SAMPLES WITH DNA

Fasted blood samples were collected before breakfast (baseline) and thereafter at 2 h, 4 h, 6 h, 24 h, 7 d, 14 d, after the tracer intake.

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 7, 2016

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

November 7, 2016

Record last verified: 2016-11