Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules

NCT ID: NCT02168738

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subject

Keywords

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nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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13-C labeled PC-DHA

Group Type ACTIVE_COMPARATOR

13-C labeled AceDoPC-DHA

Intervention Type DRUG

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-DHA

Intervention Type DRUG

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-DHA

Intervention Type DRUG

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-DHA

Group Type ACTIVE_COMPARATOR

13-C labeled AceDoPC-DHA

Intervention Type DRUG

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-DHA

Intervention Type DRUG

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-DHA

Intervention Type DRUG

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 AceDoPC-DHA

Group Type EXPERIMENTAL

13-C labeled AceDoPC-DHA

Intervention Type DRUG

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-DHA

Intervention Type DRUG

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-DHA

Intervention Type DRUG

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

Interventions

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13-C labeled AceDoPC-DHA

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

Intervention Type DRUG

13-C labeled TG-DHA

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

Intervention Type DRUG

13-C labeled PC-DHA

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male
* Aged of 60 to 70 years
* Body Mass Index of 20 to 30 kg/m2
* Glycaemic and lipid parameters normal

Exclusion Criteria

* Smokers more than ten cigarettes/day
* Medical history of personal or family dyslipidemia
* Medication that could interfere with lipid metabolism
Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de Recherche en Nutrition Humaine Rhône-Alpes, 165 chemin du Grand Revoyet,

Pierre-Bénite, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 31963708 (View on PubMed)

Related Links

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Other Identifiers

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2012.778

Identifier Type: -

Identifier Source: org_study_id