Trial | NCT02230345  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    14
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).
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).
Study Started
Mar 31
2014
Primary Completion
Dec 31
2014
Study Completion
Jul 31
2015
Last Update
Aug 21
2015
Estimate

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 names: LGG

Dietary Supplement Acidified milk

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

  • Other names: Milk

Probiotic yogurt Experimental

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

Acidified milk Active Comparator

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

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
No Results Posted