Clinical trial NCT02230345: Effects of a Probiotics on the Health of Normal Young Males
Official title: Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Dyslipidemia
Keywords: Probiotic
Yoghourt
Inflammation
Metabolomics
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Agroscope Liebefeld-Posieux Research Station ALP
First posted: 2014-09-03
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

Eligibility 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

Primary outcomes:
measure: Metabolomic analyses
timeFrame: 6 hours
Secondary outcomes:
measure: Glucose
timeFrame: 6 hours
measure: Insulin
timeFrame: 6 hours
measure: Glucagon like polypeptide-1
timeFrame: 6 hours
measure: Gastric inhibitory polypeptide
timeFrame: 6 hours
measure: Total cholesterol
timeFrame: 6 hours
measure: LDL-cholesterol
timeFrame: 6 hours
measure: HDL-cholesterol
timeFrame: 6 hours
measure: Non esterified fatty acids
timeFrame: 6 hours
measure: Triglycerides
timeFrame: 6 hours
measure: Interleukin-6
timeFrame: 6 hours
measure: Chemokine CCK2
timeFrame: 6 hours
measure: Chemokine CCK5
timeFrame: 6 hours
measure: Tunour necrosis factor alpha
timeFrame: 6 hours
measure: Lipo-poly-saccharide
timeFrame: 6 hours
Other outcomes:
measure: Transcriptomic analyses
timeFrame: 6 hours
Locations:
city: Lausanne
country: Switzerland
facility: Clinical research center, Lausanne University hospital
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Francois P Pralong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.