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NCT02168738 Clinical Trial

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

Healthy Subject Clinical Trial

— AceDoPC  

Official title:
Bioavailability of DHA-TG (Docosahexaenoic Triglyceride), DHA-PC (Docosahexaenoic Phosphatidylcholine) and AcedoPC (1-acetyl-2-docosahexaenoic-glycerophosphocholine) in Human

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02168738
Other study ID # 2012.778
Secondary ID
Status Completed
Phase N/A
First received March 21, 2014
Last updated August 26, 2016
Start date March 2014
Est. completion date April 2015

Study information
Verified date August 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 60 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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
• 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
• 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

Locations
Country Name City State
France Centre de Recherche en Nutrition Humaine Rhône-Alpes, 165 chemin du Grand Revoyet, Pierre Benite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of 13C-DHA in red blood cells 6 hours after product ingestion At Day 1 No
Secondary Concentration of 13C-DHA in plasma lipids 6 hours after product ingestion At Day 1 No
Secondary Concentration of 13C-DHA in platelets 6 hours after product ingestion At Day 1 No
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