ClinicalTrials.gg
Not yet recruitingNCT06553482Updated Aug 15, 2024

FatMax Training on Metabolic and Epigenetic Parameters

An interventional study of FatMAx training intervention and FatMax and physical endurance exercise intervention in Overweight and Obesity and Body Weight Changes, sponsored by Universidad Autonoma de Baja California. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universidad Autonoma de Baja California · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 212 studies in Obesity with a site in Mexico — 42 open to participants now, 61 under way, 29 of them phase 3. Obesity · Mexico.

Planned enrollment
74th of 190
156 · median 104
Started
2025
with 14 others
No phase
99 of 212
15 open now
Primary completion
2026-08
later than 23 of 60 live
Registered
154th of 212
by date
Lead sponsor
6 of 212
Universidad Autonoma de Baja California

Among the 212 studies in Obesity with a site in Mexico, this one is the 74th largest by planned enrollment of the 190 interventional ones that give a count, is one of 15 that started in 2025, is one of 99 with no phase, reaches primary completion later than 23 of the 60 other live ones, and was the 154th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

42 of the 212 studies in Obesity with a site in Mexico are open now. Recruiting first, the newest first:

37 more — sign in →

All 42 open studies →

A study can be open while its sites in Mexico have not opened yet or have stopped. Only those recruiting at a site in Mexico →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 35 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 212 studies in Obesity with a site in Mexico, or all of them as a file.
02

Study summary

Exercise is an essential pillar for the health of all individuals, as it contributes to physical, mental, and emotional well-being. Various international organizations, such as the World Health Organization, advocate for the integration of exercise into healthy lifestyles, recognizing its im-portance in disease prevention and improving quality of life. However, despite the general consensus on its value, there is no universal agreement on specific prescriptions for vulnerable groups, highlighting the need for personalized approaches that consider the unique characteristics and needs of each individual. It has been proposed that a moderate aerobic exercise training program could promote positive outcomes in individuals living with overweight and obesity, particularly with an emphasis on reducing injury risk, ensuring high adherence, and achieving favorable health changes. In this regard, the present protocol establishes the basis for a randomized clinical trial based on exercise prescription at the maximal fat oxidation rate in young individuals with overweight and obesity, with a duration of 16 weeks. Throughout the study, biochemical changes (cholesterol, glucose, triglycerides, and inflammatory markers), metabolic changes (de-termination of fat and carbohydrate utilization rates during rest and exercise), and epigenetic changes (focusing on microRNAs associated with adipogenesis, inflammation, and fat metabolism) will be monitored.

Read the detailed description

Obesity is a public health problem that affects millions of people in Mexico and around the world. This disease has not only increased alarmingly in recent decades but has also been recognized as one of the main risk factors for chronic diseases such as dia-betes, cardiovascular disease, and certain types of cancer. By 2022, it was estimated that 890 million adults were living with obesity and the trend continues to in-crease with obesity occurring at younger and younger ages.

The critical levels of this disease urgently demand the need to address this crisis on multiple fronts. Traditional strategies to combat obesity have focused primarily on individual responsibility, emphasizing the need to improve diet and increase physical activity. However, reducing obesity to a mere problem of willpower is insufficient to under-stand the complexity of the problem, which involves genetic, psychological, social, eco-nomic, environmental and, above all, individual factors, where dietary and exercise pre-scription is fundamental for its efficacy and adherence by those affected.

In this sense, it is crucial to conduct studies that explore the effectiveness of training and physical activity programs specifically designed for people with obesity. These pro-grams should not only focus on improving biological markers of health, such as body fat reduction, lipid profile improvement, maintenance of lean mass or exercise-associated injury limitations, but also on promoting long-term adherence and the creation of healthy habits. Understanding how to adapt exercise to the specific needs of this population is essential to develop more effective and sustainable interventions.

If these issues are not specifically addressed, the consequences will be serious. The prevalence of obesity will continue to rise, increasing the number of people at risk of de-veloping chronic diseases, reducing their life expectancy and quality of life. In addition, the health care system will face increased costs and pressure, which will make this silent pandemic even more difficult to manage. Thus, the present protocol aims to evaluate the effect of a personalized physical training program at maximum fat oxidation (FatMax) for 16 weeks on biochemical, metabolic and epigenetic parameters in overweight and obese young adults.

The subjects assigned to each group will participate in a randomized clinical trial, with a duration of 16 weeks of intervention. Measurements of all variables will be taken on the first day of the evaluation (considered the basal state) and at the end of 16 weeks of the intervention according to the group in which they were randomized, to be followed by sta-tistical analysis of the data. The variables contemplated involve assessments of body composition and physical capacities, biochemical variables, epigenetic variables and alternate variables.

03

Conditions studied

  • Overweight and Obesity
  • Body Weight Changes

Browse trials for

04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 156 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universidad Autonoma de Baja California is the lead sponsor of 33 studies on the registry; 12 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Both genders
  • Daily energy expenditure \<4 METs
  • ≥25 kg/m2
  • Acceptance of

Exclusion criteria

Exclusion/elimination Criteria:

  • ≥100 ml of alcohol consumption per week
  • Consume a dietary supplement or pharmacological treatment
  • Have limitations to perform regular physical activity
  • Have a chronic non-communicable disease
  • Answer "yes" to any of the questions on the Physical Activity Readiness- Questionnaire for Everyone (PAR-Q+); which represents a health risk.
  • \<80% attendance at exercise sessions
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    FatMax group

    low-intensity exercise training sessions (FatMax zone)

    Other: FatMAx training intervention

  • Experimental
    FatMAx and musuclar endurance exercise group

    FatMax zone exercises as well as muscular resistance exercises

    Other: FatMax and physical endurance exercise intervention

  • Active comparator
    Control

    Group without physical activity intervention

    Other: Control

Interventions

  • OtherFatMAx training intervention

    FatMax training program on a treadmill or stationary bicycle, whichever is more convenient for them

  • OtherFatMax and physical endurance exercise intervention

    FatMax training program on a treadmill or stationary bicycle, whichever is more convenient for them, with muscular endurance exercise

  • OtherControl

    No intervention pf physical activity

07

What researchers measure

Primary outcomes

  1. Body composition change

    Changes in body composition (fat mass and muscle mass) after the intervention

    Time frame: 16 weeks

Secondary outcomes

  1. Changes in lipid profile

    Changes in total cholesterol, high-density lipoprotein cholesterol (c-HDL), low-density lipoprotein cholesterol (c-LDL), triglycerides

    Time frame: 16 weeks

  2. Changes in epigenetic markers

    Changes in microRNAs involved in inflammatory processes (miR-15, miR-29c, miR-30a, miR-142/3, miR-181a), adipogenesis (miR-188-5p, miR-146b-5p, miR-103, miR-107, miR-125b), and fatty acid metabolism (miR-33, miR-335, miR-370, miR-758)

    Time frame: 16 weeks

08

Study locations

1 site
  • Medical and Psychology School
    Tijuana, California 22390, Mexico
09

References and documents

Publications

  • Chavez-Guevara IA, Urquidez-Romero R, Perez-Leon JA, Gonzalez-Rodriguez E, Moreno-Brito V, Ramos-Jimenez A. Chronic Effect of Fatmax Training on Body Weight, Fat Mass, and Cardiorespiratory Fitness in Obese Subjects: A Meta-Analysis of Randomized Clinical Trials. Int J Environ Res Public Health. 2020 Oct 28;17(21):7888. doi: 10.3390/ijerph17217888. PubMed 33126461 ↗
  • Brun JF, Myzia J, Varlet-Marie E, Raynaud de Mauverger E, Mercier J. Beyond the Calorie Paradigm: Taking into Account in Practice the Balance of Fat and Carbohydrate Oxidation during Exercise? Nutrients. 2022 Apr 12;14(8):1605. doi: 10.3390/nu14081605. PubMed 35458167 ↗
  • Pico-Sirvent I, Manresa-Rocamora A, Aracil-Marco A, Moya-Ramon M. A Combination of Aerobic Exercise at Fatmax and Low Resistance Training Increases Fat Oxidation and Maintains Muscle Mass, in Women Waiting for Bariatric Surgery. Obes Surg. 2022 Apr;32(4):1130-1140. doi: 10.1007/s11695-022-05897-1. Epub 2022 Jan 20. PubMed 35048250 ↗
  • Chavez-Guevara IA, Amaro-Gahete FJ, Ramos-Jimenez A, Brun JF. Toward Exercise Guidelines for Optimizing Fat Oxidation During Exercise in Obesity: A Systematic Review and Meta-Regression. Sports Med. 2023 Dec;53(12):2399-2416. doi: 10.1007/s40279-023-01897-y. Epub 2023 Aug 16. PubMed 37584843 ↗
  • Wang D, Zhang P, Li J. Crossover point and maximal fat oxidation training effects on blood lipid metabolism in young overweight women: a pilot study. Front Physiol. 2023 Jun 16;14:1190109. doi: 10.3389/fphys.2023.1190109. eCollection 2023. Erratum In: Front Physiol. 2024 Jul 30;15:1426727. doi: 10.3389/fphys.2024.1426727. PubMed 37398909 ↗

Individual participant data

Plan to share: No — Publication of manuscripts without any name of a participant

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Aug 2026, 19 months later.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 19 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2024
First posted
Aug 14, 2024
StartEst.
Jan 1, 2025
Primary completionEst.
Aug 1, 2026
CompletionEst.
Jan 1, 2027
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06553482
Lead sponsor
Universidad Autonoma de Baja California
Responsible party
Marco Antonio Hernández Lepe (Principal Investigator, Universidad Autonoma de Baja California) — Principal investigator
First posted
Aug 14, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Aug 15, 2024

Study contacts

María G. Delgadillo-Ramos, Dr.
Contact
lupitadelgadillo@uabc.edu.mx
6646797576
René Bassó-Quevedo, MSc
study chair · Bioethic Comittee of the Autonomous University of Baja California

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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