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

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ClinicalTrials.gov Identifier: NCT02168738
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Subject Drug: 13-C labeled AceDoPC-DHA Drug: 13-C labeled TG-DHA Drug: 13-C labeled PC-DHA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Bioavailability of DHA-TG (Docosahexaenoic Triglyceride), DHA-PC (Docosahexaenoic Phosphatidylcholine) and AcedoPC (1-acetyl-2-docosahexaenoic-glycerophosphocholine) in Human
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 13-C labeled PC-DHA Drug: 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


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


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
Active Comparator: 13-C labeled TG-DHA Drug: 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


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


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
Experimental: 13-C labeled AceDoPC-DHA Drug: 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


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


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


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of 13C-DHA in red blood cells [ Time Frame: At Day 1 ]
    6 hours after product ingestion


Secondary Outcome Measures :
  1. Concentration of 13C-DHA in plasma lipids [ Time Frame: At Day 1 ]
    6 hours after product ingestion

  2. Concentration of 13C-DHA in platelets [ Time Frame: At Day 1 ]
    6 hours after product ingestion


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168738


Locations
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France
Centre de Recherche en Nutrition Humaine Rhône-Alpes, 165 chemin du Grand Revoyet,
Pierre Benite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Additional Information:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02168738    
Other Study ID Numbers: 2012.778
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Keywords provided by Hospices Civils de Lyon:
nutrition