Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553482
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
FatMax Training on Metabolic and Epigenetic Parameters
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None