FatMax Training on Metabolic and Epigenetic Parameters

August 13, 2024 updated by: Marco Antonio Hernández Lepe, Universidad Autonoma de Baja California

Impact of Exercise Training at Maximal Fat Oxidation (FatMax) Intensity on Metabolic and Epigenetic Parameters in Subjects With Excessive Body Mass: Study Protocol of a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • California
      • Tijuana, California, Mexico, 22390
        • Medical and Psychology School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Both genders
  • Daily energy expenditure <4 METs
  • Body mass index ≥25 kg/m2
  • Acceptance of informed consent

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FatMax group
low-intensity exercise training sessions (FatMax zone)
Other: FatMAx training intervention
FatMax training program on a treadmill or stationary bicycle, whichever is more convenient for them
Experimental: FatMAx and musuclar endurance exercise group
FatMax zone exercises as well as muscular resistance exercises
Other: FatMax and physical endurance exercise intervention
FatMax training program on a treadmill or stationary bicycle, whichever is more convenient for them, with muscular endurance exercise
Active Comparator: Control
Group without physical activity intervention
Other: Control
No intervention pf physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition change
Time Frame: 16 weeks
Changes in body composition (fat mass and muscle mass) after the intervention
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in lipid profile
Time Frame: 16 weeks
Changes in total cholesterol, high-density lipoprotein cholesterol (c-HDL), low-density lipoprotein cholesterol (c-LDL), triglycerides
16 weeks
Changes in epigenetic markers
Time Frame: 16 weeks
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)
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Baja California

Investigators

  • Study Chair: René Bassó-Quevedo, MSc, Bioethic Comittee of the Autonomous University of Baja California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNC-2023-69

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Publication of manuscripts without any name of a participant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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