Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Healthy Women
In brief
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 facts
- Study ID
- NCT06746220
- Run by
- Centre Hospitalier Régional d'Orléans
- People needed
- 120
- Starts
- 2024-09-16
- Expected to finish
- 2027-12-15
- Last updated by the study team
- 2025-12-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Center Hospitalier Universitaire d'Orléans — Orléans, France (enrolling)
Full record on ClinicalTrials.gov
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