NCT02168738

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

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

March 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

March 21, 2014

Last Update Submit

December 13, 2025

Conditions

Keywords

nutrition

Outcome Measures

Primary Outcomes (1)

  • Concentration of 13C-DHA in red blood cells

    6 hours after product ingestion

    At Day 1

Secondary Outcomes (2)

  • Concentration of 13C-DHA in plasma lipids

    At Day 1

  • Concentration of 13C-DHA in platelets

    At Day 1

Study Arms (3)

13-C labeled PC-DHA

ACTIVE COMPARATOR
Drug: 13-C labeled AceDoPC-DHADrug: 13-C labeled TG-DHADrug: 13-C labeled PC-DHA

13-C labeled TG-DHA

ACTIVE COMPARATOR
Drug: 13-C labeled AceDoPC-DHADrug: 13-C labeled TG-DHADrug: 13-C labeled PC-DHA

13-C labeled AceDoPC-DHA

EXPERIMENTAL
Drug: 13-C labeled AceDoPC-DHADrug: 13-C labeled TG-DHADrug: 13-C labeled PC-DHA

Interventions

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-DHA13-C labeled PC-DHA13-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

13-C labeled AceDoPC-DHA13-C labeled PC-DHA13-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

13-C labeled AceDoPC-DHA13-C labeled PC-DHA13-C labeled TG-DHA

Eligibility Criteria

Age60 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pierre-Bénite, 69310, France

Location

Related Publications (1)

  • 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.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

June 20, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations