NCT07184177

Brief Summary

Overweight and obesity are defined as an excessive accumulation of body fat that affects health. According to data from the World Health Organization (WHO), in 2022, there were 2.5 billion adults aged 18 years and older who were overweight, of whom 890 million were obese. In other words, 43% of adults aged 18 years and older were overweight, and 16% of them were obese. Overweight and obesity are key risk factors for various chronic diseases such as diabetes, hypertension, cardiovascular disease, and even some types of cancer. There is evidence that mortality from cardiovascular disease, and the incidence of cancer and diabetes, varies according to the amount of physical activity. In the context of high levels of sedentary time, higher levels of moderate to vigorous physical activity are recommended. There are various ways to treat overweight and obesity, the main ones usually being lifestyle changes, such as following a healthy diet and regular physical activity, as well as following pharmacological treatments. In this project, the focus will be on the fat metabolism generated during moderate physical activity. There are physical activity interventions aimed at increasing fat metabolism that may potentially reduce the symptoms of metabolic diseases such as obesity and type 2 diabetes. For this purpose, it is important to understand the factors that increase or decrease fat oxidation. Factors such as exercise intensity and duration are important to understand when determining maximum fat oxidation (FatMax). The aim is to develop comprehensive research that will generate knowledge and evidence on health issues with social impact through the evaluation of commercial technologies and innovative actions that promote the prevention, treatment, and resolution of national health problems such as obesity.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

September 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2026

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 13, 2025

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Heart rate at maximal fat oxidation

    Gas exchange and heart rate will be recorded throughout the exercise tests, while the rate of perceived exertion will be registered at the end of each stage using the modified Borg scale with a 0-10 rating. The average VO2 and VCO2 values of the last 2 min of each stage before RER ≥ 1.0 will be used to calculate fat and carbohydrate oxidation using the stoichiometric equations of Jeukendrup and Wallis. The maximum rate of fat oxidation and its corresponding intensity during exercise will be determined by mathematical modeling of fat oxidation kinetics, plotted against oxygen consumption (% VO2max). The symmetry, amplitude, and translation parameters of the curve will be calculated as well to represent the oxidative capacity of each subject.

    30 minutes

  • Resting heart rate

    Resting heart rate of participants using 10 different heart rate monitors

    30 minutes

Study Arms (1)

Validation group

Participants to validate 10 heart rate monitors against electrocardiogram at resting and exercise at a maximal fat oxidation rate

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Sedentary young adults aged between 18 and 35 years, all of whom will have a body mass index (BMI) ≥ 25 kg/m2. Participants will be recruited through snowball sampling.

You may qualify if:

  • Body mass index ≥ 25 kg/m2
  • Energy expenditure \< 600 METs a week
  • Acceptance of informed consent

You may not qualify if:

  • ≥100 mL of alcohol consumption per week
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 37584843BACKGROUND
  • Hernandez-Lepe MA, Hernandez-Ontiveros DA, Chavez-Guevara IA, Ramos-Jimenez A, Hernandez-Torres RP, Lopez-Fregoso RJ, Ramos-Lopez O, Amaro-Gahete FJ, Muniz-Salazar R, Olivas-Aguirre FJ. Impact of Exercise Training at Maximal Fat Oxidation Intensity on Metabolic and Epigenetic Parameters in Patients with Overweight and Obesity: Study Protocol of a Randomized Controlled Trial. J Funct Morphol Kinesiol. 2024 Oct 31;9(4):214. doi: 10.3390/jfmk9040214.

    PMID: 39584867BACKGROUND
  • 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.

    PMID: 33126461BACKGROUND

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Francisco J Olivas Aguirre, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Time Professor

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 19, 2025

Study Start

January 19, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

December 4, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Publication of original article in an indexed journal with impact factor (JCR) over 2.0.