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Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
Sponsor: Centre Hospitalier Régional d'Orléans
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-09-16
Completion Date
2027-12-15
Last Updated
2025-12-30
Healthy Volunteers
Yes
Conditions
Interventions
Microbiota sample
Microbiota sample: one sample at inclusion and one sample at the end of the study
Salivary sample
Salivary 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
Quality of life questionnaires: 5 auto-questionnaires to be filled at inclusion and at the end of the study
Nutritional evaluation
Nutritional evaluation: food diary completed by participants for 3 consecutive days at inclusion and at the end of the study
Assessment of physical health
Assessment 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
Physical 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
Treatment 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
Locations (1)
Center Hospitalier Universitaire d'Orléans
Orléans, France