Effects of a Probiotics on the Health of Normal Young Males

Study Overview
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Brief Summary
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The important role played by the GI tract microflora on the metabolic health of an individual are increasingly recognized. In this respect, the initial studies of Metchinkoff that suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora have evolved into the concept of probiotics. Probiotics are living microorganisms that bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001). Here the investigators will study, in normal young male volunteers, the potential to modulate post-prandial metabolic and inflammatory responses by the administration of a yoghourt containing the probiotic Lactobacillus rhamnosus (LGG).

Detailed Description
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This is a prospective, randomized, double-blind and cross-over study designed to evaluate the potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic and inflammatory response of normale healthy individuals. After a wash out period during which volunteers will have to follow a diet devoid of all milk or milk-derived products, they will receive, in random order, either a daily dose of the probiotic, or a daily dose of acidified milk (control) for a total of three consecutive weeks. At the end of each of these period, they will be submitted to a day of investigation, during which their metabolic and inflammatory profile will be studied following the ingestion of a standard test meal. The potential for the probiotic to modulate the metabolic and inflammatory parameters will be evaluated. The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).

Official Title
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Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers

Conditions
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Inflammation, Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Probiotic yogurt
* Dietary Supplement: Acidified milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal male with normal BMI (18.5-25 kg/m2) non smoker stable physical activity Exclusion Criteria: Food intolerance (ceoliac disease, lactose intolerance, food allergies) Particular regimen (vegetarian...) Chronic disease (any) Elevated blood pressure Regular drug treatment Antibiotics treatement in the preceding six months >4 hrs/week of physical activity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic yogurt<br>Daily administration, during two weeks, of two probiotic yogurts (200 mL each) | Dietary Supplement: Probiotic yogurt<br>* Probiotic yogurt (fermented milk with Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus- YoFlex FD-DVS YC-X11 Fr, with the addition of Lactobacillus rhamnosus GG (LGG)- Culture Collection, University of Göteborg, Sweden CCUG 34291).<br>* Other names: LGG;|
| Active Comparator: Acidified milk<br>Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk | Dietary Supplement: Acidified milk<br>* Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk<br>* Other names: Milk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic analyses | Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| Insulin | Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| Glucagon like polypeptide-1 | Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| Gastric inhibitory polypeptide | Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| Total cholesterol | Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| LDL-cholesterol | Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| HDL-cholesterol | Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| Non esterified fatty acids | Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| Triglycerides | Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo | 6 hours | 
| Interleukin-6 | Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo | 6 hours | 
| Chemokine CCK2 | Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo | 6 hours | 
| Chemokine CCK5 | Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo | 6 hours | 
| Tunour necrosis factor alpha | Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo | 6 hours | 
| Lipo-poly-saccharide | Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Yoghourt, Inflammation, Metabolomics