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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 21, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date August 29, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)		 Concentration of 13C-DHA in red blood cells [ Time Frame: At Day 1 ]
6 hours after product ingestion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • Concentration of 13C-DHA in plasma lipids [ Time Frame: At Day 1 ]
    6 hours after product ingestion
  • Concentration of 13C-DHA in platelets [ Time Frame: At Day 1 ]
    6 hours after product ingestion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules
Official Title  ICMJE Bioavailability of DHA-TG (Docosahexaenoic Triglyceride), DHA-PC (Docosahexaenoic Phosphatidylcholine) and AcedoPC (1-acetyl-2-docosahexaenoic-glycerophosphocholine) in Human
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subject
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 13-C labeled PC-DHA
    Interventions:
    • Drug: 13-C labeled AceDoPC-DHA
    • Drug: 13-C labeled TG-DHA
    • Drug: 13-C labeled PC-DHA
  • Active Comparator: 13-C labeled TG-DHA
    Interventions:
    • Drug: 13-C labeled AceDoPC-DHA
    • Drug: 13-C labeled TG-DHA
    • Drug: 13-C labeled PC-DHA
  • Experimental: 13-C labeled AceDoPC-DHA
    Interventions:
    • Drug: 13-C labeled AceDoPC-DHA
    • Drug: 13-C labeled TG-DHA
    • Drug: 13-C labeled PC-DHA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2016)		 4
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2014)		 6
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168738
Other Study ID Numbers  ICMJE 2012.778
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP