Effects of a Probiotics on the Health of Normal Young Males

NCT ID: NCT02230345

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-07-31

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).

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).

Conditions

Inflammation; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic yogurt

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

Group Type: EXPERIMENTAL

Probiotic yogurt

Intervention Type: 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).

Acidified milk

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

Group Type: ACTIVE_COMPARATOR

Acidified milk

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Acidified milk

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

LGG; Milk

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Agroscope Liebefeld-Posieux Research Station ALP

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Francois Pralong

Full professor and Head, Service of Endocrinology, Diabetology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francois P Pralong, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Clinical research center, Lausanne University hospital

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 29788433 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30721917 (View on PubMed)

Other Identifiers

392/13

Identifier Type: -

Identifier Source: org_study_id