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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02230345
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : August 21, 2015
Sponsor:
Collaborator:
Agroscope Liebefeld-Posieux Research Station ALP
Information provided by (Responsible Party):
Francois Pralong, Centre Hospitalier Universitaire Vaudois

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).

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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

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230345


Locations
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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
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Principal Investigator: Francois P Pralong, MD Centre Hospitalier Universitaire Vaudois
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Dyslipidemias
Inflammation
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases