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Overweight and Obese AdultsCOMEFITNCT06868862

Acute Effects of Isoenergetic HIIE vs. MICE on Key Parameters of Fat Mass Loss in Young Females With Overweight or Obesity

A study testing Exercise in people with Overweight and Obese Adults and High Intensity Interval Exercise (HIIE), run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Overweight and obesity, particularly increased total and/or abdominal fat mass (FM), are strongly linked to the development of cardiovascular diseases. Managing obesity effectively requires lifestyle and dietary modifications, including increased physical activity. Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteBrazil
Study dates
1 Feb 2025to 30 Dec 2026
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 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • women with overwieght or obesity (BMI: 25-35 kg/m²)

Who cannot join

  • contraceptive use
  • menopause
  • irregular menstrual cycle
  • medical contraindications to intense physical activity,
  • painful joints,
  • taking ß-blocker

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site, 1 recruiting

  • Laboratório de Fisiologia e Metabolismo Aplicados à Educação Física

    São Paulo, São Paulo, 475

    JULIANA MONIQUE LINO APARECIDO, PhD, (+55) 1196997-5162, juliana.monique@unicid.edu.br

    Nathalie Boisseau, Professor, (+33) 0684331693, nathalie.boisseau@uca.fr

    Recruiting

Other trials in Brazil

About this study

Official title: Acute Physiological Responses to Isoenergetic High-Intensity Interval vs. Moderate-Intensity Continuous Exercise in Overweight or Obese Young Females: Focus on Catecholamines, Oxygen Consumption, Lipid Utilization, and Appetite Regulation

Overweight and obesity, particularly increased total and/or abdominal fat mass (FM), are strongly linked to the development of cardiovascular diseases. Managing obesity effectively requires lifestyle and dietary modifications, including increased physical activity. Among the various exercise strategies, Moderate-Intensity Continuous Training (MICT) and High-Intensity Interval Training (HIIT) are widely recommended for reducing FM. Compared to MICT, HIIT is a time-efficient approach, often perceived as more enjoyable, and has been shown to promote greater total and abdominal fat loss in a shorter period. However, the precise mechanisms underlying this enhanced fat loss remain unclear.

This study aims to compare the acute effects of two isoenergetic exercise sessions - MICE (Moderate-Intensity Continuous Exercise) and HIIE (High-Intensity Interval Exercise) - on key physiological responses involved in fat mass loss. Specifically, we will assess plasma catecholamine levels during exercise and recovery, as well as oxygen consumption, substrate oxidation, and appetite over the 2-hour post-exercise period in young females with overweight or obesity. By elucidating the role of catecholaminergic stimulation as a potential regulator of fat mass loss, this research could provide valuable insights for optimizing exercise strategies in weight management and metabolic health.

Being tested
Exercise
Keywords
oxygen consumption, high intensity interval training, substrate oxydation, catecholamines, obesity
Medical subject headings
Overweight, Obesity

What participants receive

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

  • ExerciseOther

    Two Exercise Modalities: HIIE and MICE

Study groups in NCT06868862
Study groupRoleWhat they receive
High Intensity Interval ExerciseExperimentalHigh Intensity Interval Exercise: 5 minutes of WarmUp + 10 x (1 minute at 85% HRmax followed by 1 minute of recovery at a power equivalent to 40% of HRmax)
Receives: Other: Exercise
Moderate Intensity Continuous ExerciseExperimentalModerate Intensity Continuous Exercise: 5 minutes of WarmUp + 35 minutes at 55% HRmax
Receives: Other: Exercise

What is being measured

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

  1. Oxygen consumption during exercise and the recovery period

    Determination of oxygen consumption during exercise and 2 hours after the exercise session (HIIE and MICE). Determination from Metamax (3D Cortex).

    Measured: Measurement at rest for 20 minutes, then during warm-up for 10 minutes, then during exercise for 20 minutes and finally during 2 hours after the end of the exercise.

Secondary outcomes (4)

  1. Lipid before and after the exercise.

    Determination of lipid oxidation before and after the exercise. Lipid oxidation is measured from oxygen and carbon dioxide consumption (Metamax 3D Cortex).

    Measured: Measurement at rest for 20 minutes and then during 2 hours after the end of the exercise.

  2. Carbohydrate before and after the exercise.

    Determination of carbohydrate oxidation before and after the exercise. Carbohydrate oxidation is measured from oxygen and carbon dioxide consumption (Metamax 3D Cortex).

    Measured: Measurement at rest for 20 minutes and then during 2 hours after the end of the exercise.

  3. Catecholamines

    Determination of cathecolamines concentration in blood during exercise and 2 hours after the end of the exercise.

    Measured: 5 collections: before exercise started, at the end of exercise (exercise duration is 20-35 minutes), at 30 minutes, 60 minutes and 120 minutes after the end of exercise

  4. Energy intakes 24 hours after the exercise

    Evaluation of energy intakes after the exercise session (HIIE vs MICE). Exercise session finish at 11:30 a.m. After that, at home, participants have to complete by themselves a food-record on which they will describe all their meal during 24 hours after the end of the exercise session. It includes their lunch, dinner and their breakfast the next morning.

    Measured: 24 hours post exercise

Timeline

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

  1. First posted11 Mar 2025
  2. Study start1 Feb 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (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
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868862
Sponsor's protocol ID
CAAE: 79561024.4.0000.9487
Acronym
COMEFIT
Status last verified
Aug 2026
First submitted
21 Feb 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dupuit M, Rance M, Morel C, Bouillon P, Pereira B, Bonnet A, Maillard F, Duclos M, Boisseau N. Moderate-Intensity Continuous Training or High-Intensity Interval Training with or without Resistance Training for Altering Body Composition in Postmenopausal Women. Med Sci Sports Exerc. 2020 Mar;52(3):736-745. doi: 10.1249/MSS.0000000000002162.

    PubMed 31524825

  • Dupuit M, Boscaro A, Bonnet A, Bouillon P, Bruno P, Morel C, Rance M, Boisseau N. Acute metabolic responses after continuous or interval exercise in post-menopausal women with overweight or obesity. Scand J Med Sci Sports. 2020 Dec;30(12):2352-2363. doi: 10.1111/sms.13814. Epub 2020 Sep 18.

    PubMed 32881054

  • Cunha FA, Midgley AW, McNaughton LR, Farinatti PT. Effect of continuous and intermittent bouts of isocaloric cycling and running exercise on excess postexercise oxygen consumption. J Sci Med Sport. 2016 Feb;19(2):187-92. doi: 10.1016/j.jsams.2015.02.004. Epub 2015 Feb 23.

    PubMed 25747467

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Overweight and Obese Adults and High Intensity Interval Exercise (HIIE), run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in Brazil.

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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 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 Brazil. 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen consumption during exercise and the recovery period (time frame: Measurement at rest for 20 minutes, then during warm-up for 10 minutes, then during exercise for 20 minutes and finally during 2 hours after the end of the exercise.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06868862, which also lists 3 linked publications.

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 31 Aug 2026.

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