An interventional study of Morning Physical Training and Night Physical Training in Obesity Type I and II and Obesity and Overweight, sponsored by State University of Minas Gerais. Active, not recruiting at 1 site in Brazil. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by State University of Minas Gerais · Not applicable, Interventional, and Treatment
Obesity is a disease characterized by the accumulation of adipose tissue, which is multifactorial and can be caused by environmental, social, behavioral, biological and genetic issues, and affects people health and well-being. In this sense, it is still difficult to maintain an effective treatment for obesity, since currently in Brazil, 24% of the population is obese and 61% is overweight. Physical exercise is considered a component that promotes numerous benefits to the human body, by releasing molecules through muscle contraction that will travel throughout the body as a whole, resulting in benefits such as increased energy expenditure and, consequently, improved physical performance, which will influence a person\'s daily activities. However, the effects of physical exercise depend on some factors, such as the time and duration of the practice. In addition, the changes that occur in the body can be influenced by the time of day. Likewise, it is known how important it is to maintain adequate sleep duration at night. It is possible that the time of day when exercise is practiced influences the responses that occur in the human body. To understand this fact, obese women will undergo combined physical training (strength and aerobic exercises) performed in the morning and evening. The aim is to better understand the time of day for controlling the metabolism of obese people. And, if there is a time when people perform better in daily activities.
Therefore, the objective of this clinical trial is to evaluate whether the time of day influences the responses to combined physical training in the modulation of energy metabolism and its biochemical markers in obese women. The main questions to be answered are:
Obesity is a chronic, non-communicable, neuroendocrine and nutrimetabolic disease with multifactorial development, which results in a positive energy balance and excessive accumulation of adipose tissue. Characteristics of its metabolic profile include changes in mitochondrial architecture and in the secretion of hormones, such as insulin, which controls glucose metabolism. In obese individuals, adipocytes can undergo hypertrophy and hyperplasia processes, inducing low-grade inflammation. Conventional treatment for obesity consists of a hypocaloric diet combined with increased physical activity aimed at achieving a negative energy balance. However, the failure of these measures has highlighted the need for metabolic studies and studies of factors that may influence non-pharmacological treatments, such as physical training.
Physical training can improve the lipid profile of obesity, reducing cholesterol, trimethylamine N-oxide and sphingolipids, which are associated with risk factors for cardiovascular morbidity caused by obesity. An intervention with combined physical training (CPT) for 8 weeks can reduce waist circumference and increase maximum oxygen consumption in women with obesity. This approach can improve physiological functions that are altered due to obesity, such as hormonal control and bioenergetic efficiency, impacting physical fitness, regardless of weight loss. These improvements may arise depending on the configuration of the training load components, such as frequency, intensity, volume, repetition duration, pause and total session time, since it is a modifiable aspect and its manipulation provides different physiological responses.
In this sense, another factor to be considered is the circadian rhythm, which acts on metabolic regulation, and considering its functions it is assumed that it can influence the treatment of metabolic disorders, such as obesity, and physical performance. It is a biological event in which organisms go through the sleep-wake cycle, characterized by a 24-hour period that includes variations in physiological functions such as body temperature, sleep, physical activity, mood and cognition.
There are different sleep patterns and times for performing daily activities. Chronotype is a terminology that refers to the individual expression of circadian rhythmicity, a factor that is related to preferences for sleep time and duration, diet, and physical activity patterns, including exercise. Chronotype can be classified as: morning, intermediate, and evening. Based on this information, the circadian rhythm has been suggested as an influencer on responses to physical training. This biological clock can be impaired in people with metabolic disorders, such as obesity, while physical training can help regulate this clock. Several studies in humans and rodents have revealed that variables such as skeletal muscle strength and capacity demonstrate significant differences throughout the day. Therefore, this study hypothesizes that combined physical training, in the evening (NOT), compared to the morning (MAT), will cause more marked physiological adaptations, improving metabolic control, in female mice and women with obesity.
Thus, the general objective of the study will be to evaluate the effects of Combined Physical Training (CPT) performed in the morning versus evening on the remodeling of muscle and adipose tissue, metabolism and physical performance in women with obesity.
While the specific objectives:
Therefore, this is an exploratory, prospective and longitudinal study, which will be carried out at the Laboratory of Research in Metabolism, Physiology and Physical Exercise of the State University of Minas Gerais, Divinópolis unit, Minas Gerais, Brazil. The sample size calculation was performed based on an equation. To perform the calculation, the chosen variable was physical performance, and data from the work of Bruggisser, was used as a source. The significance level adopted was 5%, the test power was 90%, the standard deviation was 0.80 W/kg and the difference to be detected was 0.51 W/kg. The calculation showed the need for 10 participants in each experimental group, assuming a possible loss of 20% throughout the study, the sample will consist of 12 participants per group, totaling 36 individuals of the biological female sex.
The study will last a total of 12 weeks. After verifying whether the people who have shown interest meet the inclusion criteria, they will undergo a period of anthropometric assessments, body composition, energy metabolism, blood sample collection, familiarization with the training protocol and physical tests, 2 weeks before the TFC intervention. After the TFC intervention, which will last 8 weeks and be performed 3 times a week, the same series of assessments and physical tests will be repeated for 2 weeks. Also, throughout the study, food consumption will be monitored through 24-hour recalls, and participants will be advised not to change their usual diet.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
Women who will be assessed in the morning period from 7 am to 10 am and in the evening from 6 pm to 9 pm, who will not receive intervention with combined physical training.
Other: No intervention
Women who will perform the combined physical training at morning from 7 am to 10 am.
Behavioral: Morning Physical Training
Women who will perform the combined physical training at night from 6 pm to 9 pm.
Behavioral: Night Physical Training
A group of women who will perform the combined physical training (CPT) at morning from 7 am to 10 am, for 8 weeks and a frequency of 3 times per week (total = 24 sessions) with strength exercises and aerobic endurance exercises, performed in combination. In weeks 1 and 2, the strength training protocol will be performed with 2 sets of 16-20 maximum repetitions (RM). During weeks 3 to 5 with 12-16 RM. In weeks 6 to 8, 4 sets of 8-12 RM, with rests of 60s (weeks 1 and 2), 90s (weeks 3 to 5) and 105s (weeks 6 to 8). The minimum frequency is 90% of the training sessions. With the aerobic resistance protocol, there will be a gradual progression of the duration (volume) of the exercise (from 20 to 30 minutes per training session) and intensity (from 65% to 75% of HRres). In the first two weeks of training, participants will train at an intensity of 65% of HRres during weeks 3 to 5, at 70% of HRres in weeks 6 to 8, the intensity will reach 75% of HRres.
A group of women who will perform the combined physical training (CPT) at morning from 6 pm to 9 pm, for 8 weeks and a frequency of 3 times per week (total = 24 sessions) with strength exercises and aerobic endurance exercises, performed in combination. In weeks 1 and 2, the strength training protocol will be performed with 2 sets of 16-20 maximum repetitions (RM). During weeks 3 to 5 with 12-16 RM. In weeks 6 to 8, 4 sets of 8-12 RM, with rests of 60s (weeks 1 and 2), 90s (weeks 3 to 5) and 105s (weeks 6 to 8). The minimum frequency is 90% of the training sessions. With the aerobic resistance protocol, there will be a gradual progression of the duration (volume) of the exercise (from 20 to 30 minutes per training session) and intensity (from 65% to 75% of HRres). In the first two weeks of training, participants will train at an intensity of 65% of HRres during weeks 3 to 5, at 70% of HRres in weeks 6 to 8, the intensity will reach 75% of HRres.
Group of women who will not receive intervention with combined physical training, but will be evaluated before and after 8 weeks, and monitored, without any intervention with physical exercise.
Metabolomics
Blood samples will be collected before and after the eight weeks of intervention with combined physical training for analysis of the plasma metabolome, using the UPLC-MS metabolomics method.
Time frame: 7 months
Plasma glucose
Blood samples will be collected before and after the eight weeks of intervention with combined physical training for analysis of the concentration of the plasma Glucose.
Time frame: 4 months
Lipid profile
Blood samples will be collected before and after the eight weeks of intervention with combined physical training for analysis of the concentration of the Lipid profile: total cholesterol, triglycerides and lipoproteins.
Time frame: 4 months
Hormones
Blood samples will be collected before and after the eight weeks of intervention with combined physical training for analysis of the concentration of the hormones: cortisol, melatonin, corticotropin-releasing hormone (CRH) and adrenocorticotropic hormone (ACTH), insulin, growth hormone;
Time frame: 4 months
Genes expression
Blood samples will be collected before and after the eight weeks of intervention with combined physical training for analysis of the concentration of the gene expression: * Level and phase of gene expression and circadian rhythm protein: BMAL1, Per1 and RevErba; * Gene expression of energy metabolism: PGC-1a, PPARa, NR1D1
Time frame: 4 months
Cytokines
Blood samples will be collected before and after the eight weeks of intervention with combined physical training for analysis of the concentration of the Anti-inflammatory cytokines and myokines: IL-1, IL-6, IL-15, irisin, BNDF;
Time frame: 4 months
Thermographic response
Tissue temperature will be assessed by a themographic camera, before and after the eight weeks of intervention with combined physical training, with the following interest regions: supraclavicular, subscapular, abdomen, forehead, hand and back.
Time frame: 3 months
Indirect calorimetry
Indirect Calorimetry: The use of gas analyzers will allow the measurement of oxygen consumption, and carbon dioxid production to calculate the resting metabolic rate, carbohydrate and lipids oxidation, and peak oxygen consumption. They will be evaluated before and after the intervention with combined physical training.
Time frame: 3 months
anthropometric measurements
body weight (kg) and body height (cm) will be assessed to determine the body mass index, before and after the intervention.
Time frame: 3 months
Multifrequency bioimpedance
will be assessed using multifrequency tetrapolar bioelectrical impedance (BIA) (1-1000 kHz) to measure body composition (body fat, fat-free mass, muscle mass, body water), before and after the intervention.
Time frame: 3 months
Dual x-ray absorptiometry
The mineral bone content, composition of free fat mass, lean mass, muscle mass, fat mass will all be assessed by dual x-ray absorptiometry, before and after the intervention.
Time frame: 3 months
cardiopulmonary fitness
The cardiopulmonary fitness will be evaluated in two days, being one at morning (7-10 am) and another at night (6-9 pm), before and after the intervention. An ergometric test with indirect calorimetry will be performed to analyze maximum oxygen consumption.
Time frame: 3 months
Strength performance
The strength performance will be evaluated in two days by 1RM test, being one at morning (7-10 am) and another at night (6-9 pm), before and after the intervention.
Time frame: 3 months
Blood pressure monitoring
The blood pressure ( systolic and diastolic) will be evaluated during intervention, by sphygmomanometer and stethoscope.
Time frame: 3 month
Sleep Quality Index
Participants will be assessed using the following questionnaires Pittsburgh Sleep Quality Index, before and after intervention. The instrument is divided into seven components on sleep subjectivity of the current month
Time frame: 3 months
Excessive daytime sleepiness
Participants will be assessed, before and after intervention, using the following questionnaire Epwort Sleepiness, instrument to assess excessive daytime sleepiness (EDS). Measurements above 10 on the Epworth scale are associated with sleep disturbances.
Time frame: 3 months
Morningness-Eveningness questionnaire
Participants will be assessed using the following questionnaire, before and after intervention, by Morningness-Eveningness, to determine participants' preferences.
Time frame: 3 months
Behavioral of sleep
Participants will be assessed using an actigraph (Condor Instruments) will be used, which is a wristwatch specifically designed to accurately measure activity, light and temperature on the wrist and is the ideal tool for researchers and physicians in the fields of chronobiology and sleep medicine.
Time frame: 3 months
Food intake
The food intake standart of each subject will be analyzed by a nutritionist using a 24 hours food recall (24fr) Five Step Multiple Pass method. The full amount of 24fr will be thirteen (13) for each participant, being three (3) on the first week of the study, two (2) on the physical test week pre-intervention, three (3) during the intervention, two (2) on the physical test week post-intervention, and three (3) on the last week of the study.
Time frame: 3 months
Plan to share: Undecided
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State University of Minas Gerais