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Completed

NCT Number: NCT02230345

Effects of a Probiotics on the Health of Normal Young Males

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).

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Key information

Conditions

Inflammation Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical research center, Lausanne University hospital

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic yogurt

Dietary Supplement

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 names: LGG

Acidified milk

Dietary Supplement

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

Other names: Milk

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • Agroscope Liebefeld-Posieux Research Station ALP

Registry information

Official study title

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

Acronym: FFF

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 3, 2014
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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