Effects of probiotics and physical activity on women's health
Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
This study is testing whether taking probiotics, with or without exercise, can improve the health and well-being of healthy women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT06746220 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of probiotic supplementation, with or without physical activity, on the health of healthy women. Participants will be randomized into four groups: those receiving probiotics with physical activity, probiotics without physical activity, placebo with physical activity, and placebo without physical activity. The study will involve medical examinations, microbiota and salivary sample collections, and assessments of mental and physical health over a six-week follow-up period. The aim is to explore how these interventions affect body composition and overall health.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 18 and older, with a BMI between 18.5 and 30, who are university students and do not engage in regular physical activity.
Not a fit: Patients who are smokers, have existing health conditions, or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve health outcomes for women by identifying effective strategies for enhancing body composition and physiological parameters.
How similar studies have performed: While studies on probiotics and physical activity exist, this specific combination in women has not been extensively explored, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Being female 2. Age ≥ 18 years old 3. Have a BMI between 18.5 and 30 kg/m2 4. Be registered as a student at the University of Orléans 5. Be non-athletic 6. Have no contraindication to the practice of physical activity 7. All participants must sign informed consent before the start of the study Exclusion Criteria: 1. Smokers \>10 cigarettes per day 2. Having treatment for a pathology at the time of inclusion 3. Taking a probiotic supplement during the last month prior to inclusion 4. Practice physical activity regularly (150 minutes/week of moderate physical activity according to the WHO) 5. Participant under guardianship or curators 6. Pregnant or breastfeeding women 7. Menopausal women 8. Allergy to any excipient known to be present in the probiotic or placebo formulation
Where this trial is running
Orléans
- Center Hospitalier Universitaire d'Orléans — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Virgile AMIOT, Doctor — CHU Orléans
- Study coordinator: Virgile AMIOT, Doctor
- Email: virgile.amiot@chu-orleans.fr
- Phone: 0238514785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.