NCT02230345

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

July 21, 2014

Last Update Submit

August 20, 2015

Conditions

InflammationDyslipidemia

Keywords

ProbioticYoghourtInflammationMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Metabolomic analyses

    Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo

    6 hours

Secondary Outcomes (14)

  • Glucose

    6 hours

  • Insulin

    6 hours

  • Glucagon like polypeptide-1

    6 hours

  • Gastric inhibitory polypeptide

    6 hours

  • Total cholesterol

    6 hours

  • +9 more secondary outcomes

Other Outcomes (1)

  • Transcriptomic analyses

    6 hours

Study Arms (2)

Probiotic yogurt

EXPERIMENTAL

Daily administration, during two weeks, of two probiotic yogurts (200 mL each)

Dietary Supplement: Probiotic yogurt

Acidified milk

ACTIVE COMPARATOR

Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk

Dietary Supplement: Acidified milk

Interventions

Probiotic yogurtDIETARY_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).

Also known as: LGG
Probiotic yogurt
Acidified milkDIETARY_SUPPLEMENT

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

Also known as: Milk
Acidified milk

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal male with normal BMI (18.5-25 kg/m2)
  • non smoker
  • stable physical activity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical research center, Lausanne University hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 30721917DERIVED

  • 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.

    PMID: 29788433DERIVED

MeSH Terms

Conditions

InflammationDyslipidemias

Interventions

Milk

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Francois P Pralong, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor and Head, Service of Endocrinology, Diabetology and Metabolism

Study Record Dates

First Submitted

July 21, 2014

First Posted

September 3, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

CH(1)