Obesity Type I and IIMOT-timeNCT06601660
Metabolic Investigation, Physical Performance, Physical Training At Different Times of the Day in Obese Women
A study testing Morning Physical Training and Night Physical Training in people with Obesity Type I and II and Obesity and Overweight, run by State University of Minas Gerais at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Obesity Type I and II, Obesity and Overweight
- What is being tested?
- Morning Physical Training and Night Physical Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Sep 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 20 and 45 years
- not practicing physical exercise
- body mass index between 30 and 39.9 kg/m²
- without any positive response when filling out the risk stratification questionnaire
Who cannot join
- Cardiovascular comorbidity
- joint and neuromuscular injuries
- diseases that affect visual and auditory functions
- disorders related to the sleep and wake cycle
- dependent on the use of psychoactive drugs
- drug treatment that influences sleep
Show all 11Show fewer
- drug weight loss treatments
- previous bariatric surgery
- illness during the project period
- night shift workers
- attendance of 90% of the intervention with physical training
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Research Metabolism, Physiology and Exercise
Divinópolis, Minas Gerais, 35500010
About this study
Official title: Effect of Combined Physical Training At Different Times of the Day on Muscle and Adipose Tissue Remodeling, Metabolism and Physical Performance in Female Mice and Women with Obesity
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:
- Can combined physical training (CPT) performed at night have different metabolic responses than CPT in the morning?
- Can cardiopulmonary and muscular strength performance have different magnitudes of responses to CPT performed at different times of the day?
- Can combined physical training (CPT) in the evening (NOT) compared to the morning (MAT) period cause more marked physiological adaptations, improving metabolic control in women with obesity?
Read the detailed description
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:
- To evaluate in women with obesity, before, during and after the intervention with morning TFC and evening TFC: 1.1. Body composition and body thermography; 1.2. Resting energy expenditure and oxidation of substrates (carbohydrates and lipids); 1.3. Food consumption; 1.4. Physical performance (muscular and aerobic strength); 1.5. Behavioral measures of sleep (sleep duration; sleep latency; habitual sleep duration and efficiency; circadian sleep quality and typology; daytime sleepiness); 1.6. Plasma metabolome by UPLC-MS. 1.7. Hormone levels in peripheral blood (cortisol, melatonin, corticotropin-releasing hormone - CRH, and adrenocorticotropic hormone - ACTH); 1.8. The level and phase of gene expression of the circadian cycle in peripheral blood (BMAL1, CLOCK, Cry1 and 2, Per1-3) and of energy metabolism in peripheral blood (PGC-1α, PPARγ, PPARα, NR1D1); 1.9. Verify the concentration of anti- and pro-inflammatory cytokines and myokines in peripheral blood (IL-1, IL-6, TNF-α, IL-10, IL-15 irisin, adiponectin, BNDF);
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.
- Conditions
- Obesity Type I and II, Obesity and Overweight
- Being tested
- Morning Physical Training, Night Physical Training, No intervention
- Keywords
- Circadian rhythm, Adipocytes, Insulin resistance, Carbohydrate metabolism, Lipid metabolism
- Medical subject headings
- Obesity, Overweight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Physical TrainingBehavioural
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.
Night Physical TrainingBehavioural
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.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 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. Receives: Other: No intervention |
| Morning Physical Training | Experimental | Women who will perform the combined physical training at morning from 7 am to 10 am. Receives: Behavioral: Morning Physical Training |
| Night Physical Training | Experimental | Women who will perform the combined physical training at night from 6 pm to 9 pm. Receives: Behavioral: Night Physical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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;
Measured: 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
Measured: 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;
Measured: 4 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Blood pressure monitoring
The blood pressure ( systolic and diastolic) will be evaluated during intervention, by sphygmomanometer and stethoscope.
Measured: 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
Measured: 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.
Measured: 3 months
Morningness-Eveningness questionnaire
Participants will be assessed using the following questionnaire, before and after intervention, by Morningness-Eveningness, to determine participants' preferences.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Obesity Type I and IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using the randomization function of Microsoft Excel software, participants (n = 60) will be allocated into 3 experimental groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais, University of Sao Paulo, Federal University of Uberlandia
- Responsible party
- Principal investigator, Camila Fernanda Costa e Cunha Moraes Brandao, State University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601660
- Sponsor's protocol ID
- CAAE-59429722.1.0000.5115
- Other IDs
- APQ-02960-22
- Acronym
- MOT-time
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sasaki H, Hattori Y, Ikeda Y, Kamagata M, Iwami S, Yasuda S, Tahara Y, Shibata S. Forced rather than voluntary exercise entrains peripheral clocks via a corticosterone/noradrenaline increase in PER2::LUC mice. Sci Rep. 2016 Jun 8;6:27607. doi: 10.1038/srep27607.
PubMed 27271267Kim HK, Radak Z, Takahashi M, Inami T, Shibata S. Chrono-exercise: Time-of-day-dependent physiological responses to exercise. Sports Med Health Sci. 2022 Nov 30;5(1):50-58. doi: 10.1016/j.smhs.2022.11.003. eCollection 2023 Mar.
PubMed 36994180Horne JA, Ostberg O. Individual differences in human circadian rhythms. Biol Psychol. 1977 Sep;5(3):179-90. doi: 10.1016/0301-0511(77)90001-1.
PubMed 922076Takahashi M, Tahara Y, Tsubosaka M, Fukazawa M, Ozaki M, Iwakami T, Nakaoka T, Shibata S. Chronotype and social jetlag influence human circadian clock gene expression. Sci Rep. 2018 Jul 5;8(1):10152. doi: 10.1038/s41598-018-28616-2.
PubMed 29976939Bass J, Takahashi JS. Circadian integration of metabolism and energetics. Science. 2010 Dec 3;330(6009):1349-54. doi: 10.1126/science.1195027.
PubMed 21127246Chaix A, Panda S. Timing tweaks exercise. Nat Rev Endocrinol. 2019 Aug;15(8):440-441. doi: 10.1038/s41574-019-0229-z.
PubMed 31217576Gabriel BM, Zierath JR. Circadian rhythms and exercise - re-setting the clock in metabolic disease. Nat Rev Endocrinol. 2019 Apr;15(4):197-206. doi: 10.1038/s41574-018-0150-x.
PubMed 30655625Boukelia B, Gomes EC, Florida-James GD. Diurnal Variation in Physiological and Immune Responses to Endurance Sport in Highly Trained Runners in a Hot and Humid Environment. Oxid Med Cell Longev. 2018 May 9;2018:3402143. doi: 10.1155/2018/3402143. eCollection 2018.
PubMed 29861827Mirzaei K, Xu M, Qi Q, de Jonge L, Bray GA, Sacks F, Qi L. Variants in glucose- and circadian rhythm-related genes affect the response of energy expenditure to weight-loss diets: the POUNDS LOST Trial. Am J Clin Nutr. 2014 Feb;99(2):392-9. doi: 10.3945/ajcn.113.072066. Epub 2013 Dec 11.
PubMed 24335056Conceitos da calorimetria indireta sobre distúrbios metabólicos: uma revisão narrativa. Concepts of indirect calorimetry on metabolic dis
Bondia-Pons I, Maukonen J, Mattila I, Rissanen A, Saarela M, Kaprio J, Hakkarainen A, Lundbom J, Lundbom N, Hyotylainen T, Pietilainen KH, Oresic M. Metabolome and fecal microbiota in monozygotic twin pairs discordant for weight: a Big Mac challenge. FASEB J. 2014 Sep;28(9):4169-79. doi: 10.1096/fj.14-250167. Epub 2014 May 20.
PubMed 24846387Lee JH, Park A, Oh KJ, Lee SC, Kim WK, Bae KH. The Role of Adipose Tissue Mitochondria: Regulation of Mitochondrial Function for the Treatment of Metabolic Diseases. Int J Mol Sci. 2019 Oct 4;20(19):4924. doi: 10.3390/ijms20194924.
PubMed 31590292Uranga RM, Keller JN. The Complex Interactions Between Obesity, Metabolism and the Brain. Front Neurosci. 2019 May 24;13:513. doi: 10.3389/fnins.2019.00513. eCollection 2019.
PubMed 31178685Kahn CR, Wang G, Lee KY. Altered adipose tissue and adipocyte function in the pathogenesis of metabolic syndrome. J Clin Invest. 2019 Oct 1;129(10):3990-4000. doi: 10.1172/JCI129187.
PubMed 31573548Bruggisser F, Knaier R, Roth R, Wang W, Qian J, Scheer FAJL. Best Time of Day for Strength and Endurance Training to Improve Health and Performance? A Systematic Review with Meta-analysis. Sports Med Open. 2023 May 19;9(1):34. doi: 10.1186/s40798-023-00577-5.
PubMed 37208462
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Physical Training At Different Times of the Day on Muscle and Adipose Tissue Remodeling, Metabolism and Physical Performance in Female Mice and Women with Obesity
- ClinicalTrials.gov ID
- NCT06601660
- Acronym / sponsor ID
- MOT-time / CAAE-59429722.1.0000.5115
- Conditions
- Obesity Type I and II, Obesity and Overweight
- Keywords
- Circadian rhythm, Adipocytes, Insulin resistance, Carbohydrate metabolism, Lipid metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- State University of Minas GeraisUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais, University of Sao Paulo, Federal University of Uberlandia
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can combined physical training (CPT) performed at night have different metabolic responses than CPT in the morning?
- Can cardiopulmonary and muscular strength performance have different magnitudes of responses to CPT performed at different times of the day?
- Can combined physical training (CPT) in the evening (NOT) compared to the morning (MAT) period cause more marked physiological adaptations, improving metabolic control in women with obesity?
Detailed description
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:
- To evaluate in women with obesity, before, during and after the intervention with morning TFC and evening TFC: 1.1. Body composition and body thermography; 1.2. Resting energy expenditure and oxidation of substrates (carbohydrates and lipids); 1.3. Food consumption; 1.4. Physical performance (muscular and aerobic strength); 1.5. Behavioral measures of sleep (sleep duration; sleep latency; habitual sleep duration and efficiency; circadian sleep quality and typology; daytime sleepiness); 1.6. Plasma metabolome by UPLC-MS. 1.7. Hormone levels in peripheral blood (cortisol, melatonin, corticotropin-releasing hormone - CRH, and adrenocorticotropic hormone - ACTH); 1.8. The level and phase of gene expression of the circadian cycle in peripheral blood (BMAL1, CLOCK, Cry1 and 2, Per1-3) and of energy metabolism in peripheral blood (PGC-1α, PPARγ, PPARα, NR1D1); 1.9. Verify the concentration of anti- and pro-inflammatory cytokines and myokines in peripheral blood (IL-1, IL-6, TNF-α, IL-10, IL-15 irisin, adiponectin, BNDF);
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Using the randomization function of Microsoft Excel software, participants (n = 60) will be allocated into 3 experimental groups.
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: No interventionWomen 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. |
| Morning Physical Training | Experimental | Behavioral: Morning Physical TrainingWomen who will perform the combined physical training at morning from 7 am to 10 am. |
| Night Physical Training | Experimental | Behavioral: Night Physical TrainingWomen who will perform the combined physical training at night from 6 pm to 9 pm. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged between 20 and 45 years
- not practicing physical exercise
- body mass index between 30 and 39.9 kg/m²
- without any positive response when filling out the risk stratification questionnaire
Key exclusion criteria (11 listed)
- Cardiovascular comorbidity
- joint and neuromuscular injuries
- diseases that affect visual and auditory functions
- disorders related to the sleep and wake cycle
- dependent on the use of psychoactive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning Physical TrainingA 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. | Behavioural | Morning Physical Training |
| Night Physical TrainingA 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. | Behavioural | Night Physical Training |
| No interventionGroup 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. | Other | Control |
Primary outcome
Metabolomics
Time frame: 7 months
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.
Plasma glucose
Time frame: 4 months
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.
Lipid profile
Time frame: 4 months
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.
Hormones
Time frame: 4 months
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;
Genes expression
Time frame: 4 months
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
Cytokines
Time frame: 4 months
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;
13 secondary outcomes
Thermographic response
Time frame: 3 months
Indirect calorimetry
Time frame: 3 months
anthropometric measurements
Time frame: 3 months
Multifrequency bioimpedance
Time frame: 3 months
Dual x-ray absorptiometry
Time frame: 3 months
cardiopulmonary fitness
Time frame: 3 months
Strength performance
Time frame: 3 months
Blood pressure monitoring
Time frame: 3 month
Sleep Quality Index
Time frame: 3 months
Excessive daytime sleepiness
Time frame: 3 months
Morningness-Eveningness questionnaire
Time frame: 3 months
Behavioral of sleep
Time frame: 3 months
Food intake
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 27271267Sasaki H, Hattori Y, Ikeda Y, Kamagata M, Iwami S, Yasuda S, Tahara Y, Shibata S. Forced rather than voluntary exercise entrains peripheral clocks via a corticosterone/noradrenaline increase in PER2::LUC mice. Sci Rep. 2016 Jun 8;6:27607. doi: 10.1038/srep27607.
- Background: PubMed 36994180Kim HK, Radak Z, Takahashi M, Inami T, Shibata S. Chrono-exercise: Time-of-day-dependent physiological responses to exercise. Sports Med Health Sci. 2022 Nov 30;5(1):50-58. doi: 10.1016/j.smhs.2022.11.003. eCollection 2023 Mar.
- Background: PubMed 922076Horne JA, Ostberg O. Individual differences in human circadian rhythms. Biol Psychol. 1977 Sep;5(3):179-90. doi: 10.1016/0301-0511(77)90001-1.
- Background: PubMed 29976939Takahashi M, Tahara Y, Tsubosaka M, Fukazawa M, Ozaki M, Iwakami T, Nakaoka T, Shibata S. Chronotype and social jetlag influence human circadian clock gene expression. Sci Rep. 2018 Jul 5;8(1):10152. doi: 10.1038/s41598-018-28616-2.
- Background: PubMed 21127246Bass J, Takahashi JS. Circadian integration of metabolism and energetics. Science. 2010 Dec 3;330(6009):1349-54. doi: 10.1126/science.1195027.
- Background: PubMed 31217576Chaix A, Panda S. Timing tweaks exercise. Nat Rev Endocrinol. 2019 Aug;15(8):440-441. doi: 10.1038/s41574-019-0229-z.
- Background: PubMed 30655625Gabriel BM, Zierath JR. Circadian rhythms and exercise - re-setting the clock in metabolic disease. Nat Rev Endocrinol. 2019 Apr;15(4):197-206. doi: 10.1038/s41574-018-0150-x.
- Background: PubMed 29861827Boukelia B, Gomes EC, Florida-James GD. Diurnal Variation in Physiological and Immune Responses to Endurance Sport in Highly Trained Runners in a Hot and Humid Environment. Oxid Med Cell Longev. 2018 May 9;2018:3402143. doi: 10.1155/2018/3402143. eCollection 2018.
- Background: PubMed 24335056Mirzaei K, Xu M, Qi Q, de Jonge L, Bray GA, Sacks F, Qi L. Variants in glucose- and circadian rhythm-related genes affect the response of energy expenditure to weight-loss diets: the POUNDS LOST Trial. Am J Clin Nutr. 2014 Feb;99(2):392-9. doi: 10.3945/ajcn.113.072066. Epub 2013 Dec 11.
- BackgroundConceitos da calorimetria indireta sobre distúrbios metabólicos: uma revisão narrativa. Concepts of indirect calorimetry on metabolic dis
- Background: PubMed 24846387Bondia-Pons I, Maukonen J, Mattila I, Rissanen A, Saarela M, Kaprio J, Hakkarainen A, Lundbom J, Lundbom N, Hyotylainen T, Pietilainen KH, Oresic M. Metabolome and fecal microbiota in monozygotic twin pairs discordant for weight: a Big Mac challenge. FASEB J. 2014 Sep;28(9):4169-79. doi: 10.1096/fj.14-250167. Epub 2014 May 20.
- Background: PubMed 31590292Lee JH, Park A, Oh KJ, Lee SC, Kim WK, Bae KH. The Role of Adipose Tissue Mitochondria: Regulation of Mitochondrial Function for the Treatment of Metabolic Diseases. Int J Mol Sci. 2019 Oct 4;20(19):4924. doi: 10.3390/ijms20194924.
- American College of Sports Medicine position stand. Progression models in resistance training for healthy adultsLink provided by the sponsor.
- ACSM's Guidelines for Exercise Testing and Prescription, 11th editionLink provided by the sponsor.
- Tabela para Avaliação do Consumo Alimentar em Medidas Caseiras 4a ediçãoLink provided by the sponsor.
- Ciência do treinamento desportivoLink provided by the sponsor.
- MUSCULAÇÃO: Variáveis Estruturais Programas de Treinamento Força MuscularLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Physical Training and Night Physical Training in people with Obesity Type I and II and Obesity and Overweight, run by State University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics (time frame: 7 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06601660, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.