RecruitingNot ApplicableNCT06746220

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


Sponsor

Centre Hospitalier Régional d'Orléans

Enrollment

120 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Assessment of physical health, Microbiota sample, and others for people with healthy women. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMicrobiota sample

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

OTHERSalivary sample

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

OTHERQuality of life questionnaires

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

OTHERNutritional evaluation

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

OTHERAssessment 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.

OTHERPhysical 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.

OTHERTreatment 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


Locations(1)

Center Hospitalier Universitaire d'Orléans

Orléans, France

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NCT06746220


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