Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake

Study Overview
=================
Brief Summary
-----------------
Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details. This is an exploratory study aiming at determining the plasma level of MCT and their metabolites after oral intake of Peptamen.

Detailed Description
-----------------
20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single day. Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline

Official Title
-----------------
Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Peptamen 1.5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females Aged between 20 and 65 years old BMI in the normal range (18.5 to 25.0 kg/m2) Having signed his/her consent form Exclusion Criteria: Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine) Medically diagnosed anemia based on a blood formula Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis) Smokers (anamnesis) Pregnancy (anamnesis) Under corticoids or hormone (adrenal, thyroid) treatment Alcohol intake: > 2 units a day (anamnesis) Consumption of illicit drugs (anamnesis) Having given blood within the last month, or willing to make a blood donation until one month following the end of the study Subject who cannot be expected to comply with the study procedures, including consuming the test product Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peptamen 1.5<br>500 mL of Peptamen 1.5 | Dietary Supplement: Peptamen 1.5<br>* Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of plasma Medium Chain Triglycerides (MCT) | Tmax, Cmax and AUC for MCTs as compared to baseline. | over 8 hours post intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of plasma MCT metabolites such as free fatty acids | Tmax, Cmax and AUC for MCT metabolites as compared to baseline | over 8 hours post intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medium Chain Triglycerides, Medium Chain Triglycerides metabolites, Peptamen 1.5