NCT06746220 Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
| NCT ID | NCT06746220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional d'Orléans |
| Condition | Healthy Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-09-16 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Being female 2. Age ≥ 18 years old 3. Have a BMI between 18.5 and 30 kg/m2 4. Be registered as a student at the University of Orléans 5. Be non-athletic 6. Have no contraindication to the practice of physical activity 7. All participants must sign informed consent before the start of the study Exclusion Criteria: 1. Smokers \>10 cigarettes per day 2. Having treatment for a pathology at the time of inclusion 3. Taking a probiotic supplement during the last month prior to inclusion 4. Practice physical activity regularly (150 minutes/week of moderate physical activity according to the WHO) 5. Participant under guardianship or curators 6. Pregnant or breastfeeding women 7. Menopausal women 8. Allergy to any excipient known to be present in the probiotic or placebo formulation
Contact & Investigator
Virgile AMIOT, Doctor
PRINCIPAL INVESTIGATOR
CHU Orléans
Frequently Asked Questions
Who can join the NCT06746220 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Healthy Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746220 currently recruiting?
Yes, NCT06746220 is actively recruiting participants. Contact the research team at virgile.amiot@chu-orleans.fr for enrollment information.
Where is the NCT06746220 trial being conducted?
This trial is being conducted at Orléans, France.
Who is sponsoring the NCT06746220 clinical trial?
NCT06746220 is sponsored by Centre Hospitalier Régional d'Orléans. The principal investigator is Virgile AMIOT, Doctor at CHU Orléans. The trial plans to enroll 120 participants.