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

Study Overview
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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.

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

Conditions
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Healthy Subject

Intervention / Treatment
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* Drug: 13-C labeled AceDoPC-DHA
* Drug: 13-C labeled TG-DHA
* Drug: 13-C labeled PC-DHA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 13-C labeled PC-DHA<br> | Drug: 13-C labeled AceDoPC-DHA<br>* 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<br>Drug: 13-C labeled TG-DHA<br>* 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<br>Drug: 13-C labeled PC-DHA<br>* 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<br>|
| Active Comparator: 13-C labeled TG-DHA<br> | Drug: 13-C labeled AceDoPC-DHA<br>* 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<br>Drug: 13-C labeled TG-DHA<br>* 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<br>Drug: 13-C labeled PC-DHA<br>* 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<br>|
| Experimental: 13-C labeled AceDoPC-DHA<br> | Drug: 13-C labeled AceDoPC-DHA<br>* 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<br>Drug: 13-C labeled TG-DHA<br>* 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<br>Drug: 13-C labeled PC-DHA<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of 13C-DHA in red blood cells | 6 hours after product ingestion | At Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of 13C-DHA in plasma lipids | 6 hours after product ingestion | At Day 1 | 
| Concentration of 13C-DHA in platelets | 6 hours after product ingestion | At Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition