- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957188
Metabolism of Omega-3 and Omega-6 During Healthy Aging
November 2, 2016 updated by: Mélanie Plourde, Université de Sherbrooke
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
13
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Young and elderly healthy participants
Description
Inclusion Criteria:
- six young (18-30 y old) and six older (≥ 70 y old)
- healthy non medicated participants.
Exclusion Criteria:
- 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,
- ongoing or past intensive physical training.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
October 24, 2016
First Submitted That Met QC Criteria
November 2, 2016
First Posted (Estimate)
November 6, 2016
Study Record Updates
Last Update Posted (Estimate)
November 6, 2016
Last Update Submitted That Met QC Criteria
November 2, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 13C EPA and 13C AA metabolism
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.