Clinical trial NCT06746220: Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
Official title: Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Women
Keywords: Microbiota
Probiotics
Physical activity
Health
women
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, comparative, double-blind, randomized, monocentric study to explore effects of PA and/or PS on healthy women.
Primary purpose: OTHER

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Effect of physical activity on muscle mass in healthy women
timeFrame: Measure of muscle mass will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on muscle mass in healthy women
timeFrame: 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:
measure: Effect of physical activity on physical condition
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of physical activity on physical condition
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of physical activity on physical condition
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on physical condition
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on physical condition
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on physical condition
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of physical activity on eating behavior
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on eating behavior
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: effect of prebiotics naturally present in food on the composition of the microbiota
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of physical activity on microbiota
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on microbiota
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: . Effect of physical activity on salivary cortisol
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: . Effect of probiotic supplementation on salivary cortisol
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: . Effect of physical activity on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: . Effect of physical activity on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: . Effect of physical activity on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: . Effect of physical activity on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: . Effect of physical activity on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on quality of life
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of physical activity on fat mass
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
measure: Effect of probiotic supplementation on fat mass
timeFrame: Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)
Other outcomes:
Locations:
city: Orleans
country: France
facility: Center Hospitalier Universitaire d'Orléans
Study officials:
affiliation: CHU Orléans
name: Virgile AMIOT, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Allen 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.
citation: Alvarez-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.
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citation: Aya 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.
citation: Angelakis 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.
citation: Bastianelli 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.
citation: Boisseau 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.