Effects of a Probiotics on the Health of Normal Young Males (FFF)
Primary Purpose
Inflammation, Dyslipidemia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Probiotic yogurt
Acidified milk
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation focused on measuring Probiotic, Yoghourt, Inflammation, Metabolomics
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
Sites / Locations
- Clinical research center, Lausanne University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Probiotic yogurt
Acidified milk
Arm Description
Daily administration, during two weeks, of two probiotic yogurts (200 mL each)
Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk
Outcomes
Primary Outcome Measures
Metabolomic analyses
Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo
Secondary Outcome Measures
Glucose
Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo
Insulin
Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo
Glucagon like polypeptide-1
Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo
Gastric inhibitory polypeptide
Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo
Total cholesterol
Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
LDL-cholesterol
Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
HDL-cholesterol
Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Non esterified fatty acids
Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo
Triglycerides
Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo
Interleukin-6
Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo
Chemokine CCK2
Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo
Chemokine CCK5
Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo
Tunour necrosis factor alpha
Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo
Lipo-poly-saccharide
Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo
Full Information
NCT ID
NCT02230345
First Posted
July 21, 2014
Last Updated
August 20, 2015
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Agroscope Liebefeld-Posieux Research Station ALP
1. Study Identification
Unique Protocol Identification Number
NCT02230345
Brief Title
Effects of a Probiotics on the Health of Normal Young Males
Acronym
FFF
Official Title
Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Agroscope Liebefeld-Posieux Research Station ALP
4. Oversight
Data Monitoring Committee
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Dyslipidemia
Keywords
Probiotic, Yoghourt, Inflammation, Metabolomics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic yogurt
Arm Type
Experimental
Arm Description
Daily administration, during two weeks, of two probiotic yogurts (200 mL each)
Arm Title
Acidified milk
Arm Type
Active Comparator
Arm Description
Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic yogurt
Other Intervention Name(s)
LGG
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Acidified milk
Other Intervention Name(s)
Milk
Intervention Description
Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk
Primary Outcome Measure Information:
Title
Metabolomic analyses
Description
Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Glucose
Description
Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
Insulin
Description
Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
Glucagon like polypeptide-1
Description
Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
Gastric inhibitory polypeptide
Description
Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
Total cholesterol
Description
Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
LDL-cholesterol
Description
Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
HDL-cholesterol
Description
Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
Non esterified fatty acids
Description
Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
Triglycerides
Description
Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
Title
Interleukin-6
Description
Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo
Time Frame
6 hours
Title
Chemokine CCK2
Description
Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo
Time Frame
6 hours
Title
Chemokine CCK5
Description
Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo
Time Frame
6 hours
Title
Tunour necrosis factor alpha
Description
Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo
Time Frame
6 hours
Title
Lipo-poly-saccharide
Description
Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo
Time Frame
6 hours
Other Pre-specified Outcome Measures:
Title
Transcriptomic analyses
Description
Kinetics of gene expression in white blood cells during the 6 hours after meal ingestion, in presence of yogurt or placebo
Time Frame
6 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois P Pralong, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical research center, Lausanne University hospital
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30721917
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.
Results Reference
derived
PubMed Identifier
29788433
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.
Results Reference
derived
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Effects of a Probiotics on the Health of Normal Young Males
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