Gut Microbiota and Obesity: A Role for Probiotics.
Ludovico Abenavoli, Emidio Scarpellini, Carmela Colica...
https://pubmed.ncbi.nlm.nih.gov/31703257Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06746220
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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of probiotic supplementation and physical activity on the health of healthy women who are university students and do not regularly practice sports. This prospective, randomized, double-blind study aims to understand how these interventions influence body composition, muscle mass, mental and physical health, and microbiota balance. The study is motivated by the important role intestinal microbiota plays in overall health, including immune function, hormone regulation, and digestion, which can be affected by diet, medications, contraceptive use, and physical activity levels. Participants will be randomly assigned to one of four groups: probiotic with physical activity, probiotic without physical activity, placebo with physical activity, or placebo without physical activity. The probiotic used, Lactibiane ae Reference, contains four specific strains and is taken daily as one capsule for six weeks. Those in the physical activity groups will engage in two 45-minute sessions per week involving muscle strengthening and endurance exercises, while others will remain sedentary but receive weekly phone contacts to support adherence. Throughout the study, participants will undergo medical examinations, including ECG and body measurements, and provide samples of intestinal microbiota and morning saliva to measure cortisol. They will complete questionnaires assessing mental health and quality of life and perform tests of strength and endurance. Nutritional intake will be recorded via a food diary. These assessments will be conducted at the start and end of the six-week intervention to measure changes in muscle mass, physical condition, eating behavior, microbiota composition, salivary cortisol, quality of life, and fat mass. The study will last about two months per participant.
CONDITIONS
Brief 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
You may qualify if you...
- 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 Orl�e9ans
- Not regularly practicing sports (non-athletic)
- No contraindication to physical activity
- Signed informed consent before study start
You will not qualify if you...
- Smoking more than 10 cigarettes per day
- Currently receiving treatment for any pathology
- Taking probiotic supplements within one month prior to inclusion
- Practicing physical activity regularly (150 minutes or more per week)
- Under legal guardianship or curatorship
- Pregnant or breastfeeding
- Menopausal women
- Allergy to any known ingredient in the probiotic or placebo capsules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical examination including ECG and anthropometric measurements
Baseline Assessments
Duration - 1 day
Participants complete initial evaluations including collection of microbiota and salivary samples, quality of life questionnaires, nutritional evaluations, and physical health assessments.
1 visit (in-person) to perform all baseline assessments
Treatment
Duration - 6 weeks
Participants take daily capsules of probiotic or placebo for 6 weeks. Those assigned to physical activity groups perform two 45-minute exercise sessions per week focused on muscle strengthening and endurance, while sedentary groups receive weekly phone calls to support adherence.
Two physical activity sessions per week for 6 weeks for active groups; weekly phone calls for sedentary groups
End-of-Treatment Assessments
Duration - 1 day
Participants repeat the initial tests including microbiota and salivary sample collection, quality of life questionnaires, nutritional evaluations, and physical health assessments to measure changes after the intervention.
1 visit (in-person) to perform all end-of-treatment assessments
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
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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Published Research Related To This Trial
Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans.
Jacob M Allen, Lucy J Mailing, Grace M Niemiro...
https://pubmed.ncbi.nlm.nih.gov/29166320Effects of Probiotics and Synbiotics on Weight Loss in Subjects with Overweight or Obesity: A Systematic Review.
Valentina Álvarez-Arraño, Sandra Martín-Peláez
https://pubmed.ncbi.nlm.nih.gov/34684633Association between physical activity and changes in intestinal microbiota composition: A systematic review.
Viviana Aya, Alberto Flórez, Luis Perez...
https://pubmed.ncbi.nlm.nih.gov/33630874Effects of exercise and physical activity on gut microbiota composition and function in older adults: a systematic review.
Viviana Aya, Paula Jimenez, Enrique Muñoz...
https://pubmed.ncbi.nlm.nih.gov/37308839The relationship between gut microbiota and weight gain in humans.
Emmanouil Angelakis, Fabrice Armougom, Matthieu Million...
https://pubmed.ncbi.nlm.nih.gov/22191449The effect of different contraceptive methods on the vaginal microbiome.
Carlo Bastianelli, Manuela Farris, Paola Bianchi...
https://pubmed.ncbi.nlm.nih.gov/33863265The Nutrition-Microbiota-Physical Activity Triad: An Inspiring New Concept for Health and Sports Performance.
Nathalie Boisseau, Nicolas Barnich, Christelle Koechlin-Ramonatxo
https://pubmed.ncbi.nlm.nih.gov/35267899