FatMax Training on Metabolic and Epigenetic Parameters

NCT06553482 | Not Yet Recruiting DMC

• 1 other identifier: LNC-2023-69
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity; Body Weight Changes

Outcome Measures

Primary Outcomes (1)

• Body composition change

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

  16 weeks

Secondary Outcomes (2)

• Changes in lipid profile

  16 weeks

• Changes in epigenetic markers

  16 weeks

Study Arms (3)

FatMax group

EXPERIMENTAL

low-intensity exercise training sessions (FatMax zone)

Other: FatMAx training intervention

FatMAx and musuclar endurance exercise group

EXPERIMENTAL

FatMax zone exercises as well as muscular resistance exercises

Other: FatMax and physical endurance exercise intervention

Control

ACTIVE COMPARATOR

Group without physical activity intervention

Other: Control

Interventions

FatMAx training intervention OTHER

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

FatMax group

FatMax and physical endurance exercise intervention OTHER

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

FatMAx and musuclar endurance exercise group

Control OTHER

No intervention pf physical activity

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Medical and Psychology School

Tijuana, California, 22390, Mexico

Location

Related Publications (6)

• 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: 33126461 BACKGROUND

• 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.

  PMID: 35458167 BACKGROUND

• 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.

  PMID: 35048250 BACKGROUND

• 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: 37584843 BACKGROUND

• 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.

  PMID: 37398909 BACKGROUND

• 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: 39584867 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Body Weight Changes

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• René Bassó-Quevedo, MSc

  Bioethic Comittee of the Autonomous University of Baja California

  STUDY CHAIR

Central Study Contacts

María G. Delgadillo-Ramos, Dr.

CONTACT

6646797576; lupitadelgadillo@uabc.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical Analysis will be conducted without knowledge of gropus allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)