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

Condition(s) studied

Investigational drug(s) / intervention(s)

Microbiota sample: Microbiota sample: one sample at inclusion and one sample at the end of the study

Salivary sample: Salivary sample: one sample at inclusion and one sample at the end of the study. In the morning, on an empty stomach.

Quality of life questionnaires: Quality of life questionnaires: 5 auto-questionnaires to be filled at inclusion and at the end of the study

Nutritional evaluation: Nutritional evaluation: food diary completed by participants for 3 consecutive days at inclusion and at the end of the study

Assessment of physical health: Assessment of physical health : 3 tests to assess strength and endurance. These tests will be performed at inclusion and at the end of the study.

Physical activity: Physical activity: 2 sessions per week for 6 weeks. For each session, 45 minutes of physical activity consisting of muscle strengthening and endurance exercises.

Treatment with placebo or probiotic: Treatment with placebo or probiotic: 1 capsule per day during 42 consecutive days. In the morning, on an empty stomach with a large glass of water 20 minutes before the meal

Study 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

Primary outcome measure(s)

• Effect of physical activity on muscle mass in healthy women — Measure of muscle mass will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
  Assessment of muscle mass with an impedance meter
• Effect of probiotic supplementation on muscle mass in healthy women — Measure of muscle mass will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
  Assessment of muscle mass with an impedance meter

Trial sites (1)

More Centre Hospitalier Régional d'Orléans trials in France

Other trials for the same condition