Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients

Study Overview
=================
Brief Summary
-----------------
This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects.

Detailed Description
-----------------
In this study, the investigators aim to investigate the effect of various lipid types on GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in nutritional solutions. Moreover, this will allow us to assess whether existing clinical formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.

Official Title
-----------------
Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients

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

Intervention / Treatment
-----------------
* Dietary Supplement: meal intake
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI : 19 - 24.9 kg.m-2 Normal fasting glycemia Having obtained his informed consent. Exclusion Criteria: Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease (arterial hypertension), as determined by the medical screening visit and a blood analysis. Have had a gastrointestinal surgery (with the exception of appendices resection). Malabsorption disorders Lactose intolerance Significant weight loss during the past three months (more than 5% of initial weight) Have a regular consumption of medication Regular supplements (vitamins and minerals) intake during the previous month Have an alcohol intake: > 2 units a day Smoker (more than 2 cigarettes a day) Illicit substances intake, as stated on the medical screening questionnaire Allergy to any food or medication Anaemia defined by a number of erythrocytes or hemoglobin Hb or hematocrit Ht which are inferior to laboratory normal ranges Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study Intense physical activity > 3 hours per week Currently participating or having participated in another clinical trial during the past month. Volunteer who cannot be expected to comply with the protocol, including consuming rapidly the study products, chronic medication intake

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipid 1<br>Meal intake | Dietary Supplement: meal intake<br>* Intake of meals characterized by lipid composition<br>|
| Placebo Comparator: Lipid-free<br>Maltodextrine + proteins | Dietary Supplement: Placebo<br> <br> |
| Active Comparator: Lipid 2<br>Meal intake | Dietary Supplement: meal intake<br>* Intake of meals characterized by lipid composition<br>|
| Active Comparator: Lipid 3<br>Meal intake | Dietary Supplement: meal intake<br>* Intake of meals characterized by lipid composition<br>|
| Active Comparator: Lipid 4<br>meal intake | Dietary Supplement: meal intake<br>* Intake of meals characterized by lipid composition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-2 and GLP-1 kinetics | GLP-2 and GLP-1 are measured using Elisa | changes from baseline to 4 hours following meal intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal and metabolic hormones | Those hormones will be measured based on enzymatic technics | Changes from baseline to 4 hours following meal intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy