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Effects of a Probiotics on the Health of Normal Young Males

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02230345
Acronym
FFF
Enrollment
14
Registered
2014-09-03
Start date
2014-03-31
Completion date
2015-07-31
Last updated
2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Dyslipidemia

Keywords

Probiotic, Yoghourt, Inflammation, Metabolomics

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).

Interventions

DIETARY_SUPPLEMENTProbiotic 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).

DIETARY_SUPPLEMENTAcidified milk

Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk

Sponsors

Agroscope Liebefeld-Posieux Research Station ALP
CollaboratorOTHER
Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolomic analyses6 hoursKinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo

Secondary

MeasureTime frameDescription
Glucagon like polypeptide-16 hoursKinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo
Gastric inhibitory polypeptide6 hoursKinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo
Total cholesterol6 hoursKinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
LDL-cholesterol6 hoursKinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
HDL-cholesterol6 hoursKinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Glucose6 hoursKinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo
Insulin6 hoursKinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo
Triglycerides6 hoursKinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo
Interleukin-66 hoursKinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo
Chemokine CCK26 hoursKinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo
Chemokine CCK56 hoursKinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo
Tunour necrosis factor alpha6 hoursKinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo
Lipo-poly-saccharide6 hoursKinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo
Non esterified fatty acids6 hoursKinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo

Other

MeasureTime frameDescription
Transcriptomic analyses6 hoursKinetics of gene expression in white blood cells during the 6 hours after meal ingestion, in presence of yogurt or placebo

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026