HealthyNUTRILEXNCT05370222
Adaptations of Exercise Energy Metabolism in Response to Weight Loss in Healthy Normal Weight People
A study testing Dietary weight loss intervention in people with Healthy and Weight Loss, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Weight Loss, Body Weight
- What is being tested?
- Dietary weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2022to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 18Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptations of Exercise Energy Metabolism in Response to Simulated Weight Loss Versus Effective Weight Loss Induced by Diet in Healthy Normal Weight
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.
- Conditions
- Healthy, Weight Loss, Body Weight, Diet Habit, Healthy Nutrition
- Being tested
- Dietary weight loss intervention
- Medical subject headings
- Weight Loss, Body Weight, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary weight loss interventionBehavioural
Based on an energy assessment from the data collected at T0 (energy intake, physical activity level, and resting metabolism), individualized nutritional advice will be given during an interview in order to propose a dietary rebalancing and a light caloric restriction. Caloric restriction will be generated to decrease body weight by ≈ 0.5 to 1 kg per week, as advised in several publications. As for the dietary rebalancing, it will concern in particular the distribution of macronutrients and their nature (glycemic index, nature of lipids), the fibers intake, or the reduction of consumption of refined and/or energy-dense foods based on the ANSES Recommended Dietary Allowances and on the food consumption guidelines of the National Nutrition and Health Program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Behavioral: Dietary weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Measured: Week 1
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Measured: Week 2
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Measured: Week 3
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Measured: Week 4
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Measured: Week 8
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start26 May 2022
- Primary completion31 Aug 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370222
- Sponsor's protocol ID
- RBHP 2022 DUCLOS
- Acronym
- NUTRILEX
- Status last verified
- Jul 2026
- First submitted
- 2 May 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptations of Exercise Energy Metabolism in Response to Simulated Weight Loss Versus Effective Weight Loss Induced by Diet in Healthy Normal Weight
- ClinicalTrials.gov ID
- NCT05370222
- Acronym / sponsor ID
- NUTRILEX / RBHP 2022 DUCLOS
- Conditions
- Healthy, Weight Loss, Body Weight, Diet Habit, Healthy Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Dietary weight loss intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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.
- Have achieved a minimal BMI < 18.5 or maximal BMI ≥ 25 kg/m² in adult life,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary weight loss interventionBased on an energy assessment from the data collected at T0 (energy intake, physical activity level, and resting metabolism), individualized nutritional advice will be given during an interview in order to propose a dietary rebalancing and a light caloric restriction. Caloric restriction will be generated to decrease body weight by ≈ 0.5 to 1 kg per week, as advised in several publications. As for the dietary rebalancing, it will concern in particular the distribution of macronutrients and their nature (glycemic index, nature of lipids), the fibers intake, or the reduction of consumption of refined and/or energy-dense foods based on the ANSES Recommended Dietary Allowances and on the food consumption guidelines of the National Nutrition and Health Program. | Behavioural | Experimental group |
Primary outcome
Respiratory quotient during exercise
Time frame: Week 1
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Time frame: Week 2
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Time frame: Week 3
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Time frame: Week 4
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Time frame: Week 8
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Time frame: Week 12
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary weight loss intervention in people with Healthy and Weight Loss, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory quotient during exercise (time frame: Week 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.