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

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.

Conditions

• Healthy Women

Interventions

OTHER

Nutritional evaluation

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

OTHER

Microbiota sample

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

OTHER

Salivary sample

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

OTHER

Quality of life questionnaires

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

OTHER

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.

OTHER

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.

OTHER

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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans

  lead OTHER

Principal Investigators

• Virgile AMIOT, Doctor · CHU Orléans

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-16

Primary Completion

2027-09-15

Completion

2027-12-15

Countries

• France

Study Locations