Metabolic Investigation, Physical Performance, Physical Training At Different Times of the Day in Obese Women
NCT ID: NCT06601660
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-09-16
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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:
1. Can combined physical training (CPT) performed at night have different metabolic responses than CPT in the morning?
2. Can cardiopulmonary and muscular strength performance have different magnitudes of responses to CPT performed at different times of the day?
3. 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1\. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
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.
No intervention
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.
Morning Physical Training
Women who will perform the combined physical training at morning from 7 am to 10 am.
Morning 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.
Night Physical Training
Women who will perform the combined physical training at night from 6 pm to 9 pm.
Night Physical Training
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Morning 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.
Night Physical Training
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 intervention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* drug weight loss treatments
* previous bariatric surgery
* illness during the project period
* night shift workers
* attendance of 90% of the intervention with physical training
20 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of Minas Gerais
OTHER
University of Sao Paulo
OTHER
Federal University of Uberlandia
OTHER
State University of Minas Gerais
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Camila Fernanda Costa e Cunha Moraes Brandao
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Laboratory of Research Metabolism, Physiology and Exercise
Divinópolis, Minas Gerais, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kim 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.
Horne 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.
Takahashi 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.
Bass J, Takahashi JS. Circadian integration of metabolism and energetics. Science. 2010 Dec 3;330(6009):1349-54. doi: 10.1126/science.1195027.
Chaix A, Panda S. Timing tweaks exercise. Nat Rev Endocrinol. 2019 Aug;15(8):440-441. doi: 10.1038/s41574-019-0229-z.
Gabriel 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.
Boukelia 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.
Mirzaei 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.
Conceitos 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.
Lee 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.
Uranga 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.
Kahn 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.
Bruggisser 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.
Tabela Brasileira de Composição de Alimentos - TACO
Blanton CA, Moshfegh AJ, Baer DJ, Kretsch MJ. The USDA Automated Multiple-Pass Method accurately estimates group total energy and nutrient intake. J Nutr. 2006 Oct;136(10):2594-9. doi: 10.1093/jn/136.10.2594.
La Scala Teixeira CV, Caranti DA, Oyama LM, Padovani RDC, Cuesta MGS, Moraes ADS, Cerrone LA, Affonso LHL, Gil SDS, Dos Santos RVT, Gomes RJ. Effects of functional training and 2 interdisciplinary interventions on maximal oxygen uptake and weight loss of women with obesity: a randomized clinical trial. Appl Physiol Nutr Metab. 2020 Jul;45(7):777-783. doi: 10.1139/apnm-2019-0766. Epub 2020 Jan 23.
Brandao CFC, Krempf M, Giolo de Carvalho F, Aguesse A, Junqueira-Franco MVM, Batitucci G, de Freitas EC, Noronha NY, Rodrigues GDS, Junqueira GP, Borba DA, Billon-Crossouard S, Croyal M, Marchini JS. Sphingolipid and Trimethylamine-N-Oxide (TMAO) Levels in Women with Obesity after Combined Physical Training. Metabolites. 2024 Jul 23;14(8):398. doi: 10.3390/metabo14080398.
Brandao CFC, de Carvalho FG, Souza AO, Junqueira-Franco MVM, Batitucci G, Couto-Lima CA, Fett CA, Papoti M, Freitas EC, Alberici LC, Marchini JS. Physical training, UCP1 expression, mitochondrial density, and coupling in adipose tissue from women with obesity. Scand J Med Sci Sports. 2019 Nov;29(11):1699-1706. doi: 10.1111/sms.13514. Epub 2019 Jul 22.
UCP2 expression is negatively correlated with and body fat mass after combined physical training: a pilot study
Related Links
Access external resources that provide additional context or updates about the study.
American College of Sports Medicine position stand. Progression models in resistance training for healthy adults
ACSM's Guidelines for Exercise Testing and Prescription, 11th edition
Tabela para Avaliação do Consumo Alimentar em Medidas Caseiras 4a edição
Ciência do treinamento desportivo
MUSCULAÇÃO: Variáveis Estruturais Programas de Treinamento Força Muscular
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APQ-02960-22
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CAAE-59429722.1.0000.5115
Identifier Type: -
Identifier Source: org_study_id