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

ConditionHealthy Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microbiota sample

    Other intervention

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

  • Salivary sample

    Other intervention

    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 questionnaires

    Other intervention

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

  • Nutritional evaluation

    Other intervention

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

  • Assessment of physical health

    Other intervention

    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 activity

    Other intervention

    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 probiotic

    Other intervention

    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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: A+ group (probiotic and physical activity)Experimental treatment 7 interventions
Group B: A- group (probiotic and non-physical activity)Experimental treatment 7 interventions
Group C: T+ group (placebo and physical activity)Experimental treatment 6 interventions
Group D: T- group (placebo and non-physical activity)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Effect of physical activity on muscle mass in healthy women

Assessment of muscle mass with an impedance meter

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)
2

Effect of probiotic supplementation on muscle mass in healthy women

Assessment of muscle mass with an impedance meter

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)

Secondary outcomes

1

Effect of physical activity on physical condition

Test for endurance

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)
2

Effect of physical activity on physical condition

Test for upper limb (grip strength)

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)
3

Effect of physical activity on physical condition

Test for lower limb (horizontal press test)

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)
4

Effect of probiotic supplementation on physical condition

Test for upper limb (grip strength)

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)

Other outcomes

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