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

• ClinicalTrials.gov Identifier: NCT02230345
• Recruitment Status: Completed
• First Posted: September 3, 2014
• Last Update Posted: August 21, 2015
• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborator: Agroscope Liebefeld-Posieux Research Station ALP
• Information provided by (Responsible Party): Francois Pralong, Centre Hospitalier Universitaire Vaudois

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Inflammation; Dyslipidemia	Dietary Supplement: Probiotic yogurt; Dietary Supplement: Acidified milk	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers
• Study Start Date: March 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: July 2015

Arms and Interventions

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 Name: 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 Name: Milk

Outcome Measures

Primary Outcome Measures :

1. Metabolomic analyses [ Time Frame: 6 hours ]
   Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo

Secondary Outcome Measures :

1. Glucose [ Time Frame: 6 hours ]
   Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo
2. Insulin [ Time Frame: 6 hours ]
   Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo
3. Glucagon like polypeptide-1 [ Time Frame: 6 hours ]
   Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo
4. Gastric inhibitory polypeptide [ Time Frame: 6 hours ]
   Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo
5. Total cholesterol [ Time Frame: 6 hours ]
   Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
6. LDL-cholesterol [ Time Frame: 6 hours ]
   Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
7. HDL-cholesterol [ Time Frame: 6 hours ]
   Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
8. Non esterified fatty acids [ Time Frame: 6 hours ]
   Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo
9. Triglycerides [ Time Frame: 6 hours ]
   Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo
10. Interleukin-6 [ Time Frame: 6 hours ]
    Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo
11. Chemokine CCK2 [ Time Frame: 6 hours ]
    Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo
12. Chemokine CCK5 [ Time Frame: 6 hours ]
    Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo
13. Tunour necrosis factor alpha [ Time Frame: 6 hours ]
    Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo
14. Lipo-poly-saccharide [ Time Frame: 6 hours ]
    Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo

Other Outcome Measures:

1. Transcriptomic analyses [ Time Frame: 6 hours ]
   Kinetics of gene expression in white blood cells during the 6 hours after meal ingestion, in presence of yogurt or placebo

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Switzerland

Clinical research center, Lausanne University hospital

Lausanne, Vaud, Switzerland, 1011

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Agroscope Liebefeld-Posieux Research Station ALP

Investigators

• Principal Investigator: Francois P Pralong, MD; Centre Hospitalier Universitaire Vaudois

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vionnet N, Münger LH, Freiburghaus C, Burton KJ, Pimentel G, Pralong FP, Badertscher R, Vergères 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, Bütikofer U, Pralong FP, Vionnet N, Portmann R, Vergères 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.

• Responsible Party: Francois Pralong, Full professor and Head, Service of Endocrinology, Diabetology and Metabolism, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT02230345
• Other Study ID Numbers: 392/13
• First Posted: September 3, 2014
• Last Update Posted: August 21, 2015
• Last Verified: August 2015

Keywords provided by Francois Pralong, Centre Hospitalier Universitaire Vaudois:

Probiotic; Yoghourt; Inflammation; Metabolomics

Additional relevant MeSH terms:

Dyslipidemias; Inflammation; Pathologic Processes; Lipid Metabolism Disorders; Metabolic Diseases