Effects of a Probiotics on the Health of Normal Young Males

Inflammation Clinical Trial

— FFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230345
• Other study ID #: 392/13
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: August 20, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Inflammation

Intervention

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

Locations

Country	Name	City	State
Switzerland	Clinical research center, Lausanne University hospital	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Agroscope Liebefeld-Posieux Research Station ALP

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Metabolomic analyses	Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Glucose	Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Insulin	Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Glucagon like polypeptide-1	Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Gastric inhibitory polypeptide	Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Total cholesterol	Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	LDL-cholesterol	Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	HDL-cholesterol	Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Non esterified fatty acids	Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Triglycerides	Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo	6 hours	No
Secondary	Interleukin-6	Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo	6 hours	No
Secondary	Chemokine CCK2	Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo	6 hours	No
Secondary	Chemokine CCK5	Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo	6 hours	No
Secondary	Tunour necrosis factor alpha	Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo	6 hours	No
Secondary	Lipo-poly-saccharide	Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo	6 hours	No