Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06746220

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center Hospitalier Universitaire d'Orléans

Orléans, France, 45067

Actively Recruiting

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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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