Effects of a Probiotics on the Health of Normal Young Males

Not Applicable

Completed

• Conditions: Inflammation; Dyslipidemia
• Interventions: Dietary Supplement: Acidified milk; Dietary Supplement: Probiotic yogurt

• Registration Number: NCT02230345
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

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

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).

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Primary Completion: 2014-12
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acidified milk	Acidified milk	Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk
Probiotic yogurt	Probiotic yogurt	Daily administration, during two weeks, of two probiotic yogurts (200 mL each)

Primary Outcome Measures

Name	Time	Method
Metabolomic analyses	6 hours	Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical research center, Lausanne University hospital; 🇨🇭 Lausanne, Vaud, Switzerland