Healthy VolunteersNCT02957188
Metabolism of Omega-3 and Omega-6 During Healthy Aging
An observational study of Healthy Volunteers, run by Université de Sherbrooke.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 13C eicosapentaenoic acid and 13C arachidonic acid
- Type of treatment
- Pill or oral medicine
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Young and elderly healthy participants
Who may be able to join
- six young (18-30 y old) and six older (≥ 70 y old)
- healthy non medicated participants.
Who cannot join
- 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,
Show all 16Show fewer
- 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,
- ongoing or past intensive physical training.
About this study
Official title: Metabolism of Uniformly Labelled 13C Eicosapentaenoic Acid and 13C Arachidonic Acid During Healthy Aging
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
- Conditions
- Healthy Volunteers
- Being tested
- 13C eicosapentaenoic acid and 13C arachidonic acid
- Keywords
- Eicosapentaenoic acid, Arachidonic acid, Metabolism, Healthy aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C eicosapentaenoic acid and 13C arachidonic acidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 13C eicosapentaenoic acid and 13C arachidonic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetics of 13C-EPA and 13C-AA
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Healthy Aging Research Network
- Responsible party
- Principal investigator, Mélanie Plourde, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957188
- Sponsor's protocol ID
- 13C EPA and 13C AA metabolism
- Status last verified
- Nov 2016
- First submitted
- 24 Oct 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28659301
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism of Uniformly Labelled 13C Eicosapentaenoic Acid and 13C Arachidonic Acid During Healthy Aging
- ClinicalTrials.gov ID
- NCT02957188
- Acronym / sponsor ID
- 13C EPA and 13C AA metabolism
- Conditions
- Healthy Volunteers
- Keywords
- Eicosapentaenoic acid, Arachidonic acid, Metabolism, Healthy aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Healthy Aging Research Network
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | – | Other: 13C eicosapentaenoic acid and 13C arachidonic acidSix 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. |
| Elderly | – | Other: 13C eicosapentaenoic acid and 13C arachidonic acidSix 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Young and elderly healthy participants
Key inclusion criteria (2 listed)
- six young (18-30 y old) and six older (≥ 70 y old)
- healthy non medicated participants.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C eicosapentaenoic acid and 13C arachidonic acidEach 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 | Elderly, Young |
Primary outcome
Kinetics of 13C-EPA and 13C-AA
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Derived from this study: PubMed 28659301Leveille 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of 13C-EPA and 13C-AA (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.