Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women

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.

NCT Number	NCT06746220
Lead Sponsor	Centre Hospitalier Régional d'Orléans
Conditions	Healthy Women
Enrollment	120 participants
Start Date	2024-09-16
Primary Completion	2027-09-15 (estimated)
Study Completion	2027-12-15 (estimated)
Updated on ClinicalTrials.gov	2025-12-30