About this trial
This is a prospective, comparative, double-blind, randomized, monocentric study.
The objective of this project is to evaluate the effects on health of probiotic supplementation (PS) with or without physical activity (PA). Participants who meet the study criteria will be randomized into 4 groups: probiotic and physical activity group (A+), probiotic and non-physical activity group (A-), placebo and physical activity group (T+), placebo and non-physical activity group (T-).
The probiotics used are Lactibiane® Reference provided by Pileje Laboratory. The study population are healthy women (university students) who do not practice sports. A total of 120 participants will participate.
At inclusion, each participant will undergo a medical examination, collect microbiota and salivary samples and perform different tests (questionnaires, assessments of strength and endurance). Then, a follow up phase will last 6 weeks. Each participant will receive a pillbox containing capsules (probiotic or placebo in a double-blind manner). Participants which randomized in the PA groups (A+ and A-) will perform 2 physical activity sessions per week for 6 weeks. At the end of this follow up phase, tests conducting during inclusion will be performed again.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being female
Age ≥ 18 years old
Have a BMI between 18.5 and 30 kg/m2
Be registered as a student at the University of Orléans
Disqualifiers
Smokers >10 cigarettes per day
Having treatment for a pathology at the time of inclusion
Taking a probiotic supplement during the last month prior to inclusion
Practice physical activity regularly (150 minutes/week of moderate physical activity according to the WHO)
Trial design
Parallel
Treatments tested in this trial
Microbiota sample
Other interventionMicrobiota sample: one sample at inclusion and one sample at the end of the study
Salivary sample
Other interventionSalivary sample: one sample at inclusion and one sample at the end of the study. In the morning, on an empty stomach.
Quality of life questionnaires
Other interventionQuality of life questionnaires: 5 auto-questionnaires to be filled at inclusion and at the end of the study
Nutritional evaluation
Other interventionNutritional evaluation: food diary completed by participants for 3 consecutive days at inclusion and at the end of the study
Assessment of physical health
Other interventionAssessment of physical health : 3 tests to assess strength and endurance. These tests will be performed at inclusion and at the end of the study.
Physical activity
Other interventionPhysical activity: 2 sessions per week for 6 weeks. For each session, 45 minutes of physical activity consisting of muscle strengthening and endurance exercises.
Treatment with placebo or probiotic
Other interventionTreatment with placebo or probiotic: 1 capsule per day during 42 consecutive days. In the morning, on an empty stomach with a large glass of water 20 minutes before the meal
Treatment groups
Trial outcomes
Primary outcomes
Effect of physical activity on muscle mass in healthy women
Assessment of muscle mass with an impedance meter
Effect of probiotic supplementation on muscle mass in healthy women
Assessment of muscle mass with an impedance meter
Secondary outcomes
Effect of physical activity on physical condition
Test for endurance
Effect of physical activity on physical condition
Test for upper limb (grip strength)
Effect of physical activity on physical condition
Test for lower limb (horizontal press test)
Effect of probiotic supplementation on physical condition
Test for upper limb (grip strength)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.