Actively Recruiting
Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-30
120
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Being female
- Age 18 years or older
- Body mass index (BMI) between 18.5 and 30 kg/m2
- Registered as a student at the University of Orléans
- Not practicing sports regularly (non-athletic)
- No contraindications to physical activity
- Signed informed consent before the study starts
You will not qualify if you...
- Smoking more than 10 cigarettes per day
- Currently receiving treatment for any medical condition
- Taking probiotic supplements within one month before joining
- Engaging in regular physical activity of 150 minutes or more per week
- Under legal guardianship or curatorship
- Pregnant or breastfeeding
- Menopausal
- Allergic to any ingredient in the probiotic or placebo capsules
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Center Hospitalier Universitaire d'Orléans
Orléans, France, 45067
Actively Recruiting
Research Team
V
Virgile AMIOT, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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