Healthy WomenAP-Pro-FemNCT06746220
Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
A study testing Microbiota sample, Salivary sample and Quality of life questionnaires in people with Healthy Women, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Microbiota sample, Salivary sample and Quality of life questionnaires
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2024to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being female
- Age ≥ 18 years old
- Have a BMI between 18.5 and 30 kg/m2
- Be registered as a student at the University of Orléans
- Be non-athletic
- Have no contraindication to the practice of physical activity
- All participants must sign informed consent before the start of the study
Who cannot join
- Smokers >10 cigarettes per day
- Having treatment for a pathology at the time of inclusion
- Taking a probiotic supplement during the last month prior to inclusion
- Practice physical activity regularly (150 minutes/week of moderate physical activity according to the WHO)
- Participant under guardianship or curators
- Pregnant or breastfeeding women
- Menopausal women
- Allergy to any excipient known to be present in the probiotic or placebo formulation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Center Hospitalier Universitaire d'Orléans
Orléans, 45067
Virgile AMIOT, Doctor, 0238514785 ext. +33, virgile.amiot@chu-orleans.fr
About this study
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-).
Read more
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.
Read the detailed description
Rationale: Nowadays, the intestinal microbiota is recognized as a significant factor in the health of the host organism. It has an impact on the immune system, the hypothalamo-hypophyseal adrenal axis, the overall state of the individual such as body composition and muscle activity. The intestinal microbiota has also an impact on digestion and associated problems. However, its balance is fragile and can be easily disrupted by a diet rich in proteins or carbohydrates, medications, contraceptive use or lack of physical activity (PA).To restore this balance, subjects may modify their diet, take probiotic supplements (PS) or engage in physical activity. Currently, studies remain limited, particularly regarding effects of physical activity and/or probiotic have never been explored especially in women. The objective of this project is therefore to explore effects of PS and/or PA on the mental and physical health of the holobiont.
Method: Each participant will, during an initial visit, undergo a medical examination (ECG, anthropometric measurements) to ensure there are no contraindications to engaging in physical activity or taking probiotics. Then, we will conduct the first collections of intestinal microbiota and salivary cortisol, initial evaluations of anxiety, depression, and self-esteem (indicators of mental health with questionnaires), as well as assessments of strength and endurance (indicators of physical health), body composition, and nutritional parameters. Following this, participants will be assigned to experimental groups, and we will distribute pillboxes containing capsules (probiotic or placebo in a double-blind manner). Participants in the PA groups (A+ and A-) will perform two 45-minute physical activity sessions per week for 6 weeks, consisting of muscle strengthening and endurance exercises. Participants in the sedentary groups (T+ and T-) will be contacted by phone once a week to ensure proper protocol adherence. At the end of the 6 weeks, we will repeat the tests conducted during the initial visit.
Probiotics: The probiotics used are Lactibiane® Reference, composed of 4 probiotic strains (Bifidobacterium longum LA101, Lactobacillus helveticus LA102, Lactobacillus lactis LA103, Streptococcus thermophilus LA104) dosed at 10 billion per capsule provided by Pileje laboratory. Placebos are also provided by Pileje laboratory.
Statistics: Having no proven hypothesis on the effect of physical activity and/or probiotic supplementation on the population, we started with inclusion of 120 participants in total. This will allow to highlight a moderate effect size (0.25) for the primary endpoint, under the hypothesis of an alpha risk of 0.05, with a power of 80%. and representing 20% lost to follow-up.
- Conditions
- Healthy Women
- Being tested
- Microbiota sample, Salivary sample, Quality of life questionnaires, Nutritional evaluation, Assessment of physical health
- Keywords
- Microbiota, Probiotics, Physical activity, Health, women
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota sampleOther
Microbiota sample: one sample at inclusion and one sample at the end of the study
Salivary sampleOther
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 questionnairesOther
Quality of life questionnaires: 5 auto-questionnaires to be filled at inclusion and at the end of the study
Nutritional evaluationOther
Nutritional evaluation: food diary completed by participants for 3 consecutive days at inclusion and at the end of the study
Assessment of physical healthOther
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 activityOther
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 probioticOther
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 group | Role | What they receive |
|---|---|---|
| A+ group (probiotic and physical activity) | Experimental | Microbiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic Receives: Other: Microbiota sample; Other: Salivary sample; Other: Quality of life questionnaires; Other: Nutritional evaluation; Other: Assessment of physical health; Other: Physical activity; Other: Treatment with placebo or probiotic |
| A- group (probiotic and non-physical activity) | Experimental | Microbiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic Receives: Other: Microbiota sample; Other: Salivary sample; Other: Quality of life questionnaires; Other: Nutritional evaluation; Other: Assessment of physical health; Other: Physical activity; Other: Treatment with placebo or probiotic |
| T+ group (placebo and physical activity) | Experimental | Microbiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic Receives: Other: Microbiota sample; Other: Salivary sample; Other: Quality of life questionnaires; Other: Nutritional evaluation; Other: Assessment of physical health; Other: Treatment with placebo or probiotic |
| T- group (placebo and non-physical activity) | Experimental | Microbiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic Receives: Other: Microbiota sample; Other: Salivary sample; Other: Quality of life questionnaires; Other: Nutritional evaluation; Other: Assessment of physical health; Other: Treatment with placebo or probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of physical activity on muscle mass in healthy women
Assessment of muscle mass with an impedance meter
Measured: Measure of muscle mass will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on muscle mass in healthy women
Assessment of muscle mass with an impedance meter
Measured: Measure of muscle mass will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Secondary outcomes (25)
Effect of physical activity on physical condition
Test for endurance
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on physical condition
Test for upper limb (grip strength)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on physical condition
Test for lower limb (horizontal press test)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on physical condition
Test for upper limb (grip strength)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on physical condition
Test for lower limb (horizontal press test)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on physical condition
Test for endurance
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on eating behavior
Eating behavior: food diary completed by participants for 3 consecutive days. Using specific software (nutrilog), analysis of quantitative energy intake (macronutrients and micronutrients)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on eating behavior
Eating behavior: food diary completed by participants for 3 consecutive days. Using specific software (nutrilog), analysis of quantitative energy intake (macronutrients and micronutrients)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
effect of prebiotics naturally present in food on the composition of the microbiota
effect of prebiotics: food diary completed by participants for 3 consecutive days. Using specific software (nutrilog), analysis of the content of foods rich in prebiotics (foods rich in fiber) in the diet.
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on microbiota
Microbiota: samples of stool with specific kit (MT0001G Gut Alive). Identify bacterial composition with 16S RNA sequencing
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on microbiota
Microbiota: samples of stool with specific kit (MT0001G Gut Alive). Identify bacterial composition with 16S RNA sequencing
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on salivary cortisol
Salivary cortisol: samples of saliva with specific kit ("salitubes"). Free fraction of cortisol will be analysed by Enzyme-linked immunosorbent assays (ELISA)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of probiotic supplementation on salivary cortisol
Salivary cortisol: samples of saliva with specific kit ("salitubes"). Free fraction of cortisol will be analysed by Enzyme-linked immunosorbent assays (ELISA)
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Quality of life with MOS-SF36 questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Anxiety, depression with HAD questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Self-esteem with ISP-25 questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Effects of dietary supplement with EPCA questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Daily physical activity with IPAQ questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Quality of life with MOS-SF36 questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Anxiety, depression with HAD questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Self-esteem with ISP-25 questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Effects of dietary supplement with EPCA questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Daily physical activity with IPAQ questionnaire
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on fat mass
Fat mass: assessment of fat mass with an impedance meter
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on fat mass
Fat mass: assessment of fat mass with an impedance meter
Measured: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start16 Sep 2024
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, comparative, double-blind, randomized, monocentric study to explore effects of PA and/or PS on healthy women.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virgile AMIOT, Doctor, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746220
- Sponsor's protocol ID
- CHUO-2024-01
- Acronym
- AP-Pro-Fem
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abenavoli L, Scarpellini E, Colica C, Boccuto L, Salehi B, Sharifi-Rad J, Aiello V, Romano B, De Lorenzo A, Izzo AA, Capasso R. Gut Microbiota and Obesity: A Role for Probiotics. Nutrients. 2019 Nov 7;11(11):2690. doi: 10.3390/nu11112690.
PubMed 31703257Allen JM, Mailing LJ, Niemiro GM, Moore R, Cook MD, White BA, Holscher HD, Woods JA. Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans. Med Sci Sports Exerc. 2018 Apr;50(4):747-757. doi: 10.1249/MSS.0000000000001495.
PubMed 29166320Alvarez-Arrano V, Martin-Pelaez S. Effects of Probiotics and Synbiotics on Weight Loss in Subjects with Overweight or Obesity: A Systematic Review. Nutrients. 2021 Oct 17;13(10):3627. doi: 10.3390/nu13103627.
PubMed 34684633Aya V, Florez A, Perez L, Ramirez JD. Association between physical activity and changes in intestinal microbiota composition: A systematic review. PLoS One. 2021 Feb 25;16(2):e0247039. doi: 10.1371/journal.pone.0247039. eCollection 2021.
PubMed 33630874Aya V, Jimenez P, Munoz E, Ramirez JD. Effects of exercise and physical activity on gut microbiota composition and function in older adults: a systematic review. BMC Geriatr. 2023 Jun 12;23(1):364. doi: 10.1186/s12877-023-04066-y.
PubMed 37308839Angelakis E, Armougom F, Million M, Raoult D. The relationship between gut microbiota and weight gain in humans. Future Microbiol. 2012 Jan;7(1):91-109. doi: 10.2217/fmb.11.142.
PubMed 22191449Bastianelli C, Farris M, Bianchi P, Benagiano G. The effect of different contraceptive methods on the vaginal microbiome. Expert Rev Clin Pharmacol. 2021 Jul;14(7):821-836. doi: 10.1080/17512433.2021.1917373. Epub 2021 Apr 23.
PubMed 33863265Boisseau N, Barnich N, Koechlin-Ramonatxo C. The Nutrition-Microbiota-Physical Activity Triad: An Inspiring New Concept for Health and Sports Performance. Nutrients. 2022 Feb 22;14(5):924. doi: 10.3390/nu14050924.
PubMed 35267899
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
- ClinicalTrials.gov ID
- NCT06746220
- Acronym / sponsor ID
- AP-Pro-Fem / CHUO-2024-01
- Conditions
- Healthy Women
- Keywords
- Microbiota, Probiotics, Physical activity, Health, women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Nowadays, the intestinal microbiota is recognized as a significant factor in the health of the host organism. It has an impact on the immune system, the hypothalamo-hypophyseal adrenal axis, the overall state of the individual such as body composition and muscle activity. The intestinal microbiota has also an impact on digestion and associated problems. However, its balance is fragile and can be easily disrupted by a diet rich in proteins or carbohydrates, medications, contraceptive use or lack of physical activity (PA).To restore this balance, subjects may modify their diet, take probiotic supplements (PS) or engage in physical activity. Currently, studies remain limited, particularly regarding effects of physical activity and/or probiotic have never been explored especially in women. The objective of this project is therefore to explore effects of PS and/or PA on the mental and physical health of the holobiont.
Method: Each participant will, during an initial visit, undergo a medical examination (ECG, anthropometric measurements) to ensure there are no contraindications to engaging in physical activity or taking probiotics. Then, we will conduct the first collections of intestinal microbiota and salivary cortisol, initial evaluations of anxiety, depression, and self-esteem (indicators of mental health with questionnaires), as well as assessments of strength and endurance (indicators of physical health), body composition, and nutritional parameters. Following this, participants will be assigned to experimental groups, and we will distribute pillboxes containing capsules (probiotic or placebo in a double-blind manner). Participants in the PA groups (A+ and A-) will perform two 45-minute physical activity sessions per week for 6 weeks, consisting of muscle strengthening and endurance exercises. Participants in the sedentary groups (T+ and T-) will be contacted by phone once a week to ensure proper protocol adherence. At the end of the 6 weeks, we will repeat the tests conducted during the initial visit.
Probiotics: The probiotics used are Lactibiane® Reference, composed of 4 probiotic strains (Bifidobacterium longum LA101, Lactobacillus helveticus LA102, Lactobacillus lactis LA103, Streptococcus thermophilus LA104) dosed at 10 billion per capsule provided by Pileje laboratory. Placebos are also provided by Pileje laboratory.
Statistics: Having no proven hypothesis on the effect of physical activity and/or probiotic supplementation on the population, we started with inclusion of 120 participants in total. This will allow to highlight a moderate effect size (0.25) for the primary endpoint, under the hypothesis of an alpha risk of 0.05, with a power of 80%. and representing 20% lost to follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a prospective, comparative, double-blind, randomized, monocentric study to explore effects of PA and/or PS on healthy women.
| Arm | Type | Receives |
|---|---|---|
| A+ group (probiotic and physical activity) | Experimental | Other: Microbiota sample, Other: Salivary sample, Other: Quality of life questionnaires, Other: Nutritional evaluation, Other: Assessment of physical health, Other: Physical activity, Other: Treatment with placebo or probioticMicrobiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic |
| A- group (probiotic and non-physical activity) | Experimental | Other: Microbiota sample, Other: Salivary sample, Other: Quality of life questionnaires, Other: Nutritional evaluation, Other: Assessment of physical health, Other: Physical activity, Other: Treatment with placebo or probioticMicrobiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic |
| T+ group (placebo and physical activity) | Experimental | Other: Microbiota sample, Other: Salivary sample, Other: Quality of life questionnaires, Other: Nutritional evaluation, Other: Assessment of physical health, Other: Treatment with placebo or probioticMicrobiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic |
| T- group (placebo and non-physical activity) | Experimental | Other: Microbiota sample, Other: Salivary sample, Other: Quality of life questionnaires, Other: Nutritional evaluation, Other: Assessment of physical health, Other: Treatment with placebo or probioticMicrobiota sample Salivary sample Quality of life questionnaires Nutritional evaluation Assessment of physical health Physical activity Treatment with placebo or probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being female
- Age ≥ 18 years old
- Have a BMI between 18.5 and 30 kg/m2
- Be registered as a student at the University of Orléans
- Be non-athletic
Key exclusion criteria (8 listed)
- Smokers >10 cigarettes per day
- Having treatment for a pathology at the time of inclusion
- Taking a probiotic supplement during the last month prior to inclusion
- Practice physical activity regularly (150 minutes/week of moderate physical activity according to the WHO)
- Participant under guardianship or curators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota sampleMicrobiota sample: one sample at inclusion and one sample at the end of the study | Other | A+ group (probiotic and physical activity), A- group (probiotic and non-physical activity), T+ group (placebo and physical activity), T- group (placebo and non-physical activity) |
| Salivary sampleSalivary sample: one sample at inclusion and one sample at the end of the study. In the morning, on an empty stomach. | Other | A+ group (probiotic and physical activity), A- group (probiotic and non-physical activity), T+ group (placebo and physical activity), T- group (placebo and non-physical activity) |
| Quality of life questionnairesQuality of life questionnaires: 5 auto-questionnaires to be filled at inclusion and at the end of the study | Other | A+ group (probiotic and physical activity), A- group (probiotic and non-physical activity), T+ group (placebo and physical activity), T- group (placebo and non-physical activity) |
| Nutritional evaluationNutritional evaluation: food diary completed by participants for 3 consecutive days at inclusion and at the end of the study | Other | A+ group (probiotic and physical activity), A- group (probiotic and non-physical activity), T+ group (placebo and physical activity), T- group (placebo and non-physical activity) |
| Assessment of physical healthAssessment 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 | A+ group (probiotic and physical activity), A- group (probiotic and non-physical activity), T+ group (placebo and physical activity), T- group (placebo and non-physical activity) |
| Physical activityPhysical activity: 2 sessions per week for 6 weeks. For each session, 45 minutes of physical activity consisting of muscle strengthening and endurance exercises. | Other | A+ group (probiotic and physical activity), A- group (probiotic and non-physical activity) |
| Treatment with placebo or probioticTreatment 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 | Other | A+ group (probiotic and physical activity), A- group (probiotic and non-physical activity), T+ group (placebo and physical activity), T- group (placebo and non-physical activity) |
Primary outcome
Effect of physical activity on muscle mass in healthy women
Time frame: 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
Time frame: 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
25 secondary outcomes
Effect of physical activity on physical condition
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on physical condition
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on physical condition
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on physical condition
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on physical condition
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on physical condition
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on eating behavior
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on eating behavior
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
effect of prebiotics naturally present in food on the composition of the microbiota
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on microbiota
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on microbiota
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on salivary cortisol
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of probiotic supplementation on salivary cortisol
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
. Effect of physical activity on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on quality of life
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of physical activity on fat mass
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Effect of probiotic supplementation on fat mass
Time frame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 31703257Abenavoli L, Scarpellini E, Colica C, Boccuto L, Salehi B, Sharifi-Rad J, Aiello V, Romano B, De Lorenzo A, Izzo AA, Capasso R. Gut Microbiota and Obesity: A Role for Probiotics. Nutrients. 2019 Nov 7;11(11):2690. doi: 10.3390/nu11112690.
- Background: PubMed 29166320Allen JM, Mailing LJ, Niemiro GM, Moore R, Cook MD, White BA, Holscher HD, Woods JA. Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans. Med Sci Sports Exerc. 2018 Apr;50(4):747-757. doi: 10.1249/MSS.0000000000001495.
- Background: PubMed 34684633Alvarez-Arrano V, Martin-Pelaez S. Effects of Probiotics and Synbiotics on Weight Loss in Subjects with Overweight or Obesity: A Systematic Review. Nutrients. 2021 Oct 17;13(10):3627. doi: 10.3390/nu13103627.
- Background: PubMed 33630874Aya V, Florez A, Perez L, Ramirez JD. Association between physical activity and changes in intestinal microbiota composition: A systematic review. PLoS One. 2021 Feb 25;16(2):e0247039. doi: 10.1371/journal.pone.0247039. eCollection 2021.
- Background: PubMed 37308839Aya V, Jimenez P, Munoz E, Ramirez JD. Effects of exercise and physical activity on gut microbiota composition and function in older adults: a systematic review. BMC Geriatr. 2023 Jun 12;23(1):364. doi: 10.1186/s12877-023-04066-y.
- Background: PubMed 22191449Angelakis E, Armougom F, Million M, Raoult D. The relationship between gut microbiota and weight gain in humans. Future Microbiol. 2012 Jan;7(1):91-109. doi: 10.2217/fmb.11.142.
- Background: PubMed 33863265Bastianelli C, Farris M, Bianchi P, Benagiano G. The effect of different contraceptive methods on the vaginal microbiome. Expert Rev Clin Pharmacol. 2021 Jul;14(7):821-836. doi: 10.1080/17512433.2021.1917373. Epub 2021 Apr 23.
- Background: PubMed 35267899Boisseau N, Barnich N, Koechlin-Ramonatxo C. The Nutrition-Microbiota-Physical Activity Triad: An Inspiring New Concept for Health and Sports Performance. Nutrients. 2022 Feb 22;14(5):924. doi: 10.3390/nu14050924.
Related trials for Healthy Women
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Recruiting
The Effect of Water Temperature on Heart Rate Variability and Cognition
Mental Acuity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virgile AMIOT, Doctor principal investigator
CHU Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiota sample, Salivary sample and Quality of life questionnaires in people with Healthy Women, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virgile AMIOT, Doctor (0238514785 ext. +33, virgile.amiot@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of physical activity on muscle mass in healthy women (time frame: Measure of muscle mass will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06746220, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.