UnknownNot Applicable

Adaptations of Exercise Energy Metabolism in Response to Weight Loss in Healthy Normal Weight People

France48 participantsStarted 2022-05-26

Plain-language summary

More and more normal weight people are dieting in the general population. The NUTRILEX study aims to better understand the physiological adaptations in response to weight loss in healthy normal weight individuals. After an inclusion visit to verify the eligibility criteria of the subjects, they will complete a "T0" control session. The subjects will then have to complete two phases. The first transversal phase consists of 4 randomized sessions with lunch ad libitum after a physical exercise: i) a control session (no exercise, CON); ii) an exercise session at initial body weight (BWT0); iii) an exercise session with a simulated weight loss of 3% performed on an anti-gravity treadmill (BW-3%) and; iv) an exercise session with a simulated weight loss of 6% performed on an anti-gravity treadmill (BW-6%). During the second longitudinal phase, the participants will perform a dietary rebalancing and a slight caloric restriction (dietary intervention) in order to induce a weight loss of 6% of their initial body weight. Subjects will then perform an exercise session after losing 3% (T1) and then 6% (T2) of their initial body weight.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Body mass index (BMI) between 18.5 and 24.9 kg/m², * Subjects abled to understand the information note and abled to sign the consent form, * Subjects with stable body weight (variation \< 3% of body weight) until at least 6 months, * Subjects subjected to a social security plan. Non-Criteria: * Have achieved a minimal BMI \< 18.5 or maximal BMI ≥ 25 kg/m² in adult life, * Subjects with high levels of physical activity (\> 5 h of exercise per week), * Presence of comorbidities or medical conditions that may interfere with study data, * Subjects undergoing energy restriction or physical activity weight loss program at the time of inclusion or within the past 6 months, * Taking medication that may interfere with study results, * Surgery within the last 3 months, * Person under guardianship, curatorship, or safeguard of justice; or not subject to a social security plan, * Pregnant or breastfeeding women, * Refusal to sign the consent form, * Person in a period of exclusion from another study, * Regular consumption of tobacco or alcohol, * Voluntary weight loss in the last 6 months, * Present or past eating disorders.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Respiratory quotient during exercise

Timeframe: Week 1

Respiratory quotient during exercise

Timeframe: Week 2

Respiratory quotient during exercise

Timeframe: Week 3

Respiratory quotient during exercise

Timeframe: Week 4

Respiratory quotient during exercise

Timeframe: Week 8

Respiratory quotient during exercise

Timeframe: Week 12

Trial details

NCT IDNCT05370222

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-26

Contact for this trial

Lise Laclautre

04 73 75 11 95 promo_interne_drci@chu-clermontferrand.fr

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Respiratory quotient during exercise

Timeframe: Week 1

Respiratory quotient during exercise

Timeframe: Week 2

Respiratory quotient during exercise

Timeframe: Week 3

Respiratory quotient during exercise

Timeframe: Week 4

Respiratory quotient during exercise

Timeframe: Week 8

Respiratory quotient during exercise

Timeframe: Week 12