Healthy SubjectAceDoPCNCT02168738
Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules
A study testing 13-C labeled AceDoPC-DHA, 13-C labeled TG-DHA and 13-C labeled PC-DHA in people with Healthy Subject, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway in human by using 13C labeled molecules. The circulating form of DHA plays a major role in his cerebral incorporation. Read more about this study
- Who is it for?
- Ages 60 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- 13-C labeled AceDoPC-DHA, 13-C labeled TG-DHA and 13-C labeled PC-DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Apr 2015
- Phase
- Interventional
- 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 60 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male
- Aged of 60 to 70 years
- Body Mass Index of 20 to 30 kg/m2
- Glycaemic and lipid parameters normal
Who cannot join
- Smokers more than ten cigarettes/day
- Medical history of personal or family dyslipidemia
- Medication that could interfere with lipid metabolism
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine Rhône-Alpes, 165 chemin du Grand Revoyet,
Pierre-Bénite, 69310
About this study
Official title: Bioavailability of DHA-TG (Docosahexaenoic Triglyceride), DHA-PC (Docosahexaenoic Phosphatidylcholine) and AcedoPC (1-acetyl-2-docosahexaenoic-glycerophosphocholine) in Human
The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway in human by using 13C labeled molecules.
The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this research is to confirm that some lipidic forms are best carriers for the cerebral incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.
- Conditions
- Healthy Subject
- Being tested
- 13-C labeled AceDoPC-DHA, 13-C labeled TG-DHA, 13-C labeled PC-DHA
- Keywords
- nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-C labeled AceDoPC-DHADrug
Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
The dose contains 50 mg 13C-DHA. The wash-out period is four months
13-C labeled TG-DHADrug
Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
The dose contains 50 mg 13C-DHA. The wash-out period is four months
13-C labeled PC-DHADrug
Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
The dose contains 50 mg 13C-DHA. The wash-out period is four months
| Study group | Role | What they receive |
|---|---|---|
| 13-C labeled PC-DHA | Active comparator | Not described Receives: Drug: 13-C labeled AceDoPC-DHA; Drug: 13-C labeled TG-DHA; Drug: 13-C labeled PC-DHA |
| 13-C labeled TG-DHA | Active comparator | Not described Receives: Drug: 13-C labeled AceDoPC-DHA; Drug: 13-C labeled TG-DHA; Drug: 13-C labeled PC-DHA |
| 13-C labeled AceDoPC-DHA | Experimental | Not described Receives: Drug: 13-C labeled AceDoPC-DHA; Drug: 13-C labeled TG-DHA; Drug: 13-C labeled PC-DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of 13C-DHA in red blood cells
6 hours after product ingestion
Measured: At Day 1
Secondary outcomes (2)
Concentration of 13C-DHA in plasma lipids
6 hours after product ingestion
Measured: At Day 1
Concentration of 13C-DHA in platelets
6 hours after product ingestion
Measured: At Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionApr 2015
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 SubjectStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168738
- Sponsor's protocol ID
- 2012.778
- Acronym
- AceDoPC
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hachem M, Nacir H, Picq M, Belkouch M, Bernoud-Hubac N, Windust A, Meiller L, Sauvinet V, Feugier N, Lambert-Porcheron S, Laville M, Lagarde M. Docosahexaenoic Acid (DHA) Bioavailability in Humans after Oral Intake of DHA-Containing Triacylglycerol or the Structured Phospholipid AceDoPC(R). Nutrients. 2020 Jan 18;12(1):251. doi: 10.3390/nu12010251.
PubMed 31963708
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of DHA-TG (Docosahexaenoic Triglyceride), DHA-PC (Docosahexaenoic Phosphatidylcholine) and AcedoPC (1-acetyl-2-docosahexaenoic-glycerophosphocholine) in Human
- ClinicalTrials.gov ID
- NCT02168738
- Acronym / sponsor ID
- AceDoPC / 2012.778
- Conditions
- Healthy Subject
- Keywords
- nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Jun 2014 (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 compare three lipidic forms of DHA in their metabolic pathway in human by using 13C labeled molecules.
The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this research is to confirm that some lipidic forms are best carriers for the cerebral incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 13-C labeled PC-DHA | Active comparator | Drug: 13-C labeled AceDoPC-DHA, Drug: 13-C labeled TG-DHA, Drug: 13-C labeled PC-DHA |
| 13-C labeled TG-DHA | Active comparator | Drug: 13-C labeled AceDoPC-DHA, Drug: 13-C labeled TG-DHA, Drug: 13-C labeled PC-DHA |
| 13-C labeled AceDoPC-DHA | Experimental | Drug: 13-C labeled AceDoPC-DHA, Drug: 13-C labeled TG-DHA, Drug: 13-C labeled PC-DHA |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male
- Aged of 60 to 70 years
- Body Mass Index of 20 to 30 kg/m2
- Glycaemic and lipid parameters normal
Key exclusion criteria (3 listed)
- Smokers more than ten cigarettes/day
- Medical history of personal or family dyslipidemia
- Medication that could interfere with lipid metabolism
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 |
|---|---|---|
| 13-C labeled AceDoPC-DHAEach subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C. The dose contains 50 mg 13C-DHA. The wash-out period is four months | Drug | 13-C labeled AceDoPC-DHA, 13-C labeled PC-DHA, 13-C labeled TG-DHA |
| 13-C labeled TG-DHAEach subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C. The dose contains 50 mg 13C-DHA. The wash-out period is four months | Drug | 13-C labeled AceDoPC-DHA, 13-C labeled PC-DHA, 13-C labeled TG-DHA |
| 13-C labeled PC-DHAEach subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C. The dose contains 50 mg 13C-DHA. The wash-out period is four months | Drug | 13-C labeled AceDoPC-DHA, 13-C labeled PC-DHA, 13-C labeled TG-DHA |
Primary outcome
Concentration of 13C-DHA in red blood cells
Time frame: At Day 1
6 hours after product ingestion
2 secondary outcomes
Concentration of 13C-DHA in plasma lipids
Time frame: At Day 1
Concentration of 13C-DHA in platelets
Time frame: At Day 1
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 19 Dec 2025.
- Results publication: PubMed 31963708Hachem M, Nacir H, Picq M, Belkouch M, Bernoud-Hubac N, Windust A, Meiller L, Sauvinet V, Feugier N, Lambert-Porcheron S, Laville M, Lagarde M. Docosahexaenoic Acid (DHA) Bioavailability in Humans after Oral Intake of DHA-Containing Triacylglycerol or the Structured Phospholipid AceDoPC(R). Nutrients. 2020 Jan 18;12(1):251. doi: 10.3390/nu12010251.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13-C labeled AceDoPC-DHA, 13-C labeled TG-DHA and 13-C labeled PC-DHA in people with Healthy Subject, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 3 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Concentration of 13C-DHA in red blood cells (time frame: At Day 1). 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 NCT02168738, 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 19 Dec 2025.