Effects of a Probiotics on the Health of Normal Young Males (FFF)

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

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).

Study Overview

• Status: Completed
• Conditions: Inflammation; Dyslipidemia
• Intervention / Treatment: Dietary supplement: Probiotic yogurt; Dietary supplement: Acidified milk

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Clinical research center, Lausanne University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic yogurt; Daily administration, during two weeks, of two probiotic yogurts (200 mL each)	Dietary supplement: Probiotic yogurt; 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).; Other Names: LGG
Active Comparator: Acidified milk; Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk	Dietary supplement: Acidified milk; Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk; Other Names: Milk

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcriptomic analyses	Kinetics of gene expression in white blood cells during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: Agroscope Liebefeld-Posieux Research Station ALP
• Investigators: Principal Investigator: Francois P Pralong, MD, Centre hospitalier universitaire vaudois

Publications and helpful links

General Publications

• Vionnet N, Munger LH, Freiburghaus C, Burton KJ, Pimentel G, Pralong FP, Badertscher R, Vergeres G. Assessment of lactase activity in humans by measurement of galactitol and galactonate in serum and urine after milk intake. Am J Clin Nutr. 2019 Feb 1;109(2):470-477. doi: 10.1093/ajcn/nqy296.
• Pimentel G, Burton KJ, von Ah U, Butikofer U, Pralong FP, Vionnet N, Portmann R, Vergeres G. Metabolic Footprinting of Fermented Milk Consumption in Serum of Healthy Men. J Nutr. 2018 Jun 1;148(6):851-860. doi: 10.1093/jn/nxy053.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Estimate): August 21, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Inflammation; Metabolomics; Probiotic; Yoghourt
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Lipid Metabolism Disorders; Inflammation; Dyslipidemias
• Other Study ID Numbers: 392/13