RecruitingNAINTERVENTIONAL

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

This research wants to understand how taking probiotics and/or doing physical activity can affect the health of healthy young women. We're looking at things like body make-up and general well-being. Participants, who are university students, will be put into one of four groups: taking probiotics and exercising, taking probiotics without exercising, taking a dummy pill and exercising, or taking a dummy pill without exercising. Over six weeks, some will do two exercise sessions per week, while others won't. We'll compare results before and after to see what differences unfold. This helps us learn more about how our gut health and activity levels work together.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Régional d'Orléans

Enrolment target

120

Start

16 Sep 2024

Estimated completion

15 Dec 2027

Healthy Women

What is this study about?

This study is designed to explore how probiotics (good bacteria, like those found in some yogurts) and physical activity might affect the health of young women. Many people don't realise that the bacteria in our gut (called the gut microbiota) play a big role in our overall health, influencing everything from our immune system to our mood and how our body uses energy. Things like our diet, medicines we take, and how much we move can upset this delicate balance.

While we know that probiotics and exercise can be good for us separately, scientists haven't fully understood what happens when women combine these two approaches, or which one has a bigger impact. This study aims to fill that gap. We're especially interested in how these factors might change body composition (like muscle and fat), physical fitness, and even mental well-being in healthy women.

By comparing different groups – those taking probiotics, those exercising, those doing both, and those doing neither – researchers hope to get a clearer picture of how these interventions work. The results could help us understand better ways to support women's health through simple lifestyle choices.

Key takeaways

This study explores how probiotics and/or exercise affect women's health.
Participation involves taking capsules daily and possibly exercising twice a week for six weeks.
Your gut health and general well-being will be assessed through samples and surveys.
The study helps understand how lifestyle choices impact health.
It's open to healthy female university students who don't regularly exercise.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women who are at least 18 years old and are students at the University of Orléans. To join, your Body Mass Index (BMI) should be between 18.5 and 30, which generally means you're in a healthy weight range or moderately overweight. You should also not be someone who regularly exercises a lot (more than 2.5 hours of moderate activity per week).

There are also some important reasons why you might not be able to take part. For instance, if you smoke more than 10 cigarettes a day, are currently being treated for a health condition, or have taken probiotic supplements in the last month, you wouldn't be eligible. Also, if you are pregnant, breastfeeding, have reached menopause, or are allergic to any ingredients in the probiotics or dummy pills, you cannot join. The researchers will also make sure you don't have any health conditions that would make exercise or taking probiotics unsafe for you.

Before you start, you'll need to read and sign a consent form, which explains everything about the study in detail, to make sure you're happy to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Are you currently a student at the University of Orléans?
Do you generally have a healthy weight (BMI between 18.5 and 30)?
Do you NOT regularly exercise for more than 2.5 hours per week?
Are you NOT pregnant, breastfeeding, or menopausal?
Are you NOT a heavy smoker or taking certain medications/probiotics?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will involve a few steps over a total of six weeks. First, you'll have an initial visit where a doctor will check your health to make sure you can safely take part. During this visit, you'll provide samples of your saliva and stool (poo) so researchers can look at your gut bacteria and stress levels, and you'll answer questionnaires about your well-being. You'll also do some simple tests to measure your strength and fitness.

After this, you'll be given a supply of capsules to take daily for six weeks. These will either be a probiotic or a dummy pill (placebo), and neither you nor the researchers will know which one you're taking until the study is over. If you are assigned to an exercise group, you will attend two 45-minute exercise sessions each week for these six weeks. If you are in a non-exercise group, you will still be contacted by phone once a week to check in. At the end of the six weeks, you'll come back for a final visit where all the initial tests and samples will be taken again to see what has changed. The total duration of your active participation will be these six weeks.

Potential risks and benefits

Taking part in this study could offer some benefits, such as gaining a better understanding of your own health and fitness, potentially improving your well-being if you are in an exercise or probiotic group, and contributing to important scientific knowledge. As for risks, taking a probiotic is generally safe, but like any supplement, there's a small chance of mild stomach upset or an allergic reaction if you have known allergies to ingredients. The exercise sessions will be supervised and designed for healthy individuals, but there's always a slight risk of minor muscle soreness or injury with any physical activity. Rest assured, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care or your student status.

Locations (1)

Center Hospitalier Universitaire d'Orléans
Verified postcode
Orléans, France· Recruiting

Common questions

What are probiotics?

Probiotics are live good bacteria and yeasts that live in your gut and are thought to have health benefits when consumed, often found in supplements or fermented foods.

What is a 'placebo'?

A placebo is a dummy pill that looks just like the real one but contains no active ingredients. It helps researchers compare the real treatment's effects.

Why university students?

The study aims to focus on a specific group of healthy young women, and university students fit these criteria, making the research more controlled.

Will I know if I'm taking the probiotic or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the researchers will know which capsule you're taking until the study finishes.

What kind of exercise will I do?

The exercise sessions will involve muscle strengthening and endurance exercises, lasting 45 minutes twice a week.

How to find out more

Virgile AMIOT, Doctor

virgile.amiot@chu-orleans.fr 0238514785 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.