Study title
Function Fermented Food (F3)
Template
Intervention/Observation study
title
Function Fermented Food (F3)
description
Serum metabolome and stool microbiota after daily intake of milk or probiotic yoghurt
startDate
2014-03-01 00:00:00.0
Study type
Human Intervention
Principle Investigator
Guy Vergères
Primary endpoint
Metabolic and microbiota footprint of fermented milk consumption.
Objectives
Metabolic and microbiota footprint of fermented milk consumption.
Central conclusion
Probiotic yogurt and acidified milk similarly reduce postprandial inflammation and both alter the gut microbiota. Identification of bionarkers of fermented milk consumption.
Main health-related outcome
Probiotic yogurt and acidified milk similarly reduce postprandial inflammation
Exclusion criteria
Chronic or acute disease, hypertension, regular medication, moderate or intense physical activity (exceeding 6 h/week), nutritional supplements, antibiotic
treatment in the 6 months preceding the study and a history of anaemia.
Inclusion criteria
Subjects aged 18–40 years with a
stable, healthy BMI (18·5–25·0 kg/m2), regular dietary and physical activity habits, and no evidence of dietary intolerances, restrictions or adverse reactions to dairy products
Institute
Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, 1011 Lausanne, Switzerland.
https://www.chuv.ch/fr/edm/edm-home
Collaborators involved
Grégory Pimentel, Kathryn J Burton, Ueli von Ah, Ueli Bütikofer, François P Pralong, Nathalie Vionnet, Reto Portmann, and Guy Vergères
Country (for multicentre study overall PI)
Switzerland
Clinicaltrials.gov or similar number
NCT02230345
Was the study approved by an ethics committee?
Yes
Ethical approval number
392/13, Vaud, Switzerland
Did the individuals providing data sign informed consent?
Yes
Diet short codes and descriptions
Full randomisation method (if any)
Computer random number generator
Blinding method
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Number of factors (for factorial designs only)
2
Total number of arms (Give number of distinct treatments in study)
2
Explanatory text (Give a textual account of the overall design leading to the total number of groups) or provide the study protocol.
Cross over design with 2 groups: 2 weeks daily intake of acidified milk or yoghurt; followed by 2 weeks daily intake of yoghurt or acidified milk.
Treatments (Number and types of foods, drugs or other treatments compared)
2: acidified milk or yoghurt
Number of volunteers screened N(M:xx, F: xx)
M:393
Number of volunteers enrolled N(M:xx, F: xx)
M:14
Number of subjects (Male; Female)
M:13
Start of recruitment (Start year or date)
2013-10-01 00:00:00.0
End of recruitment (End year or date)
2014-01-01 00:00:00.0
