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

ConditionHealthy Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Microbiota sample
  • Salivary sample
  • Quality of life questionnaires
  • Nutritional evaluation
  • Assessment of physical health
  • Physical activity
  • Treatment with placebo or probiotic

Treatment groups

120 Participants
are divided into 4 treatment groups