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

NCT06746220 | Recruiting

• 1 other identifier: CHUO-2024-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Women

Keywords

Microbiota; Probiotics; Physical activity; Health; women

Outcome Measures

Primary Outcomes (2)

• Effect of physical activity on muscle mass in healthy women

  Assessment of muscle mass with an impedance meter

  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

  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

  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

  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

  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

  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

  Measure of secondary endpoints will be performed at inclusion and at the end of the study (an average of 2 months after inclusion)

Study Arms (4)

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

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

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

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

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

Interventions

Quality of life questionnaires OTHER

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

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 evaluation OTHER

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

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 health OTHER

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.

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 activity OTHER

Physical activity: 2 sessions per week for 6 weeks. For each session, 45 minutes of physical activity consisting of muscle strengthening and endurance exercises.

A+ group (probiotic and physical activity); A- group (probiotic and non-physical activity)

Treatment with placebo or probiotic OTHER

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

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)

Microbiota sample OTHER

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

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 sample OTHER

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

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smokers \>10 cigarettes per day
• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Center Hospitalier Universitaire d'Orléans

Orléans, 45067, France

RECRUITING

Related Publications (8)

• 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.

  PMID: 31703257 BACKGROUND

• 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.

  PMID: 29166320 BACKGROUND

• 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.

  PMID: 34684633 BACKGROUND

• Aya 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.

  PMID: 33630874 BACKGROUND

• 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.

  PMID: 37308839 BACKGROUND

• 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.

  PMID: 22191449 BACKGROUND

• 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.

  PMID: 33863265 BACKGROUND

• 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.

  PMID: 35267899 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Therapeutics; Probiotics

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Virgile AMIOT, Doctor

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virgile AMIOT, Doctor

CONTACT

0238514785; virgile.amiot@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Open label for physical activity or no-physical activity (A versus T groups). Double-blind for placebo/probiotic supplementation (+ versus - groups)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, comparative, double-blind, randomized, monocentric study to explore effects of PA and/or PS on healthy women.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: December 24, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)