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Obesity and OverweightDELOADNCT07155746

Effect of Simulated Weight Loss on the Energy Cost of Locomotion in Overweight or Obese Adolescents

A study testing Incremental walking exercise on an AlterG treadmill (anti-gravity) in people with Obesity and Overweight, run by Centre Hospitalier Emile Roux.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Current literature suggests that part of the energy response to weight loss is not due to changes in fat mass and lean mass, but rather to a homeostatic adaptation aimed at limiting or even preventing weight loss and preserving individuals' energy reserves, an adaptation known as "adaptive thermogenesis". Read more about this study

Who is it for?
Ages 12 to 16 years
Conditions the study is for
Obesity and Overweight
What is being tested?
Incremental walking exercise on an AlterG treadmill (anti-gravity)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
12 Sep 2025to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 12 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Adolescents aged 12 to 16 (inclusive), at Tanner stage 3-5, with obesity defined as a body mass index (BMI) above the 97th percentile according to national growth charts.
  • No regular consumption of tobacco or alcohol,
  • No diet (no calorie restriction, no specific diet such as a normal-calorie diet enriched with protein, vegetarian, or other),
  • Adolescents affiliated with the social security system or equivalent,
  • Adolescent who has been informed and has given written consent to participate in the study,
  • Signed consent of both holders of parental authority (or one in the event of death, major incapacity, or withdrawal of parental authority).

Who cannot join

  • Refusal to participate in the study,
  • Refusal of consent by parents or guardians,
  • Participation in regular and intense physical and sporting activities (no more than 150 minutes of moderate structured activity per week (according to WHO recommendations),
  • Medical or surgical history deemed by the investigator to be incompatible with the study,
  • Presence of diabetes or any other condition limiting the application of either strategy being tested,
  • Adolescents undergoing energy restriction or a weight loss program through physical activity at the time of inclusion or during the previous 6 months,
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  • Taking medications that may interfere with the study results.
  • Adolescents with cardiovascular problems, i.e., subjects with a history of cardiovascular and/or neurovascular disease, as well as subjects with cardiovascular and/or neurovascular risk factors (excluding obesity/overweight).
  • Surgery in the previous 3 months,
  • Adolescents who are currently excluded from another study,
  • Pregnant or breastfeeding adolescents,
  • Adolescents under guardianship/curatorship or legal protection,
  • Parents under guardianship/curatorship or legal protection.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

David THIVEL Director of AME2P Laboratory - CLERMONT-FERRAND University contact

+ 33 04 73 40 76 79

David.thivel@uca.fr

Sandra COURNIER Centre Hospitalier Emile ROUX contact

+33 04 71 04 34 20

sandra.cournier@ch-lepuy.fr

About this study

Current literature suggests that part of the energy response to weight loss is not due to changes in fat mass and lean mass, but rather to a homeostatic adaptation aimed at limiting or even preventing weight loss and preserving individuals' energy reserves, an adaptation known as "adaptive thermogenesis". This phenomenon calls for a closer look at the respective contributions of metabolic and mechanical changes induced by weight variations, with greater consideration given to the recently proposed hypothesis of dual regulation of homeostatic energy balance involving both leptin-dependent and "gravitostatic" pathways . While leptin-dependent regulation of body weight has been described and reinforced several times since the 1950s, the gravitostatic conception of this regulation is more recent and hypothesizes that terrestrial animals use gravity to regulate their body weight through receptors and pathways that have not yet been identified. This regulation would involve adaptations in energy consumption based on body weight when working against gravity, involving weight detection by osteocytes in weight-bearing bones, and leading to feedback regulation of energy metabolism and body weight . Preclinical and clinical studies conducted on rodents and human participants have shown a reduction in body weight after several weeks of mechanical overload (simulating weight gain), explained by adaptations in their food intake and energy metabolism , adaptations suggested to be particularly due to the regulation of muscle mass. Interestingly, preliminary results from this group highlight specific post-weight loss energy adaptations to such simulated weight regain in adolescents with obesity, suggesting the establishment of specific mechanisms promoting weight regain. Indeed, after weight loss, energy metabolism during locomotion was explored with and without simulated weight regain, and interestingly, energy expenditure did not return to pre-weight loss values, as a potential means of preserving weight regain. More recently, the investigators team has been able to show that such mechanical simulation of weight gain in adolescents with obesity but stable weight does not lead to an increase in their energy expenditure during locomotion, further reinforcing a susceptibility to not activating energy defense mechanisms against this weight gain.Overall, these results suggest the presence of mechanisms for preserving body mass by conserving energy stores as a compensatory defense system against weight loss, while highlighting the absence of activation of these mechanisms in the context of simulated weight gain. Indeed, while the compensatory mechanisms implicated in response to weight fluctuations have thus far been nutritional in nature, these energy adaptations, if confirmed, would suggest an upstream activation mechanism, particularly as a tonic signal for homeostatic control.

It seems necessary to study in greater depth the energy adaptations to weight variations in young people with obesity, both metabolic and mechanical, in order to better understand the control of their energy balance and the mechanisms involved, which corresponds to the objectives of this project.

The objective of this project is therefore to study energy adaptations (energy cost and use of energy substrates) to simulated weight loss during incremental walking exercise. Adolescents with obesity will perform a walking exercise on an AlterG (anti-gravity) treadmill, first without and then with a simulated weight loss that places them in the overweight or normal weight category.

Being tested
Incremental walking exercise on an AlterG treadmill (anti-gravity)
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incremental walking exercise on an AlterG treadmill (anti-gravity)Other

    One visit with their current weight (BW) One visit with simulated weight loss in adolescents to determine their normal weight (NW-SBW) One visit with simulated weight loss in adolescents to determine their overweight status (OW-SBW).

Study groups in NCT07155746
Study groupRoleWhat they receive
Adolescents aged 12 to 16 with obesity defined as a BMI above the 97th percentileOther3 different walking exercises
Receives: Other: Incremental walking exercise on an AlterG treadmill (anti-gravity)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Energy expenditure during incremental walking exercise measured by portable calorimetry

    Energy expenditure will be assessed during walking exercise using portable indirect calorimetry (MetaMax, Inc.).

    Indirect calorimetry is one of the classic methods for measuring resting energy expenditure. The contribution of lipid and carbohydrate oxidation will be calculated indirectly by monitoring oxygen consumption and CO2 output according to double unknown equations, assuming that protein oxidation is stable and around 15%.

    Measured: 3 Months

Secondary outcomes (2)
  1. The use of energy substrates during incremental walking exercise

    Energy substrates will be assessed during walking exercise using portable indirect calorimetry (MetaMax, Inc.).

    Indirect calorimetry is one of the classic methods for measuring resting energy expenditure . The contribution of lipid and carbohydrate oxidation will be calculated indirectly by monitoring oxygen consumption and CO2 output using double unknown equations, assuming that protein oxidation is stable and in the order of 15%.

    Measured: 3 months

  2. Perception of effort during incremental walking exercise (Borg scale)

    At the end of each stage, during the incremental submaximal walking exercise, the adolescents' perception of effort will be assessed using a Borg scale. This scale consists of progressive stages from 6 to 20; 6 corresponds to a perception of very low effort, while 20 corresponds to an effort that is too intense, requiring the exercise to be stopped.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start12 Sep 2025 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07155746
Sponsor's protocol ID
RIPH2_GADEA_DELOAD
Other IDs
2025-A01209-40
Acronym
DELOAD
Status last verified
Sep 2025
First submitted
19 Aug 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Incremental walking exercise on an AlterG treadmill (anti-gravity) in people with Obesity and Overweight, run by Centre Hospitalier Emile Roux.

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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David THIVEL Director of AME2P Laboratory - CLERMONT-FERRAND University (+ 33 04 73 40 76 79, David.thivel@uca.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Energy expenditure during incremental walking exercise measured by portable calorimetry (time frame: 3 Months). 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 19 Sep 2025.

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