Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
Centre Hospitalier Régional d'Orléans
120 participants
Sep 16, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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
- Be non-athletic
- Have no contraindication to the practice of physical activity
- All participants must sign informed consent before the start of the study
Exclusion Criteria8
- 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)
- Participant under guardianship or curators
- Pregnant or breastfeeding women
- Menopausal women
- Allergy to any excipient known to be present in the probiotic or placebo formulation
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Interventions
Microbiota sample: one sample at inclusion and one sample at the end of the study
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: 5 auto-questionnaires to be filled at inclusion and at the end of the study
Nutritional evaluation: food diary completed by participants for 3 consecutive days at inclusion and at the end of the study
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: 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: 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06746220