Metabolic Investigation, Physical Performance, Physical Training At Different Times of the Day in Obese Women

NCT06601660 | Active Not Recruiting

• 2 other identifiers: CAAE-59429722.1.0000.5115APQ-02960-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Can combined physical training (CPT) performed at night have different metabolic responses than CPT in the morning?
2. 2.Can cardiopulmonary and muscular strength performance have different magnitudes of responses to CPT performed at different times of the day?
3. 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?

Conditions

Obesity Type I and II; Obesity and Overweight

Keywords

Circadian rhythm; Adipocytes; Insulin resistance; Carbohydrate metabolism; Lipid metabolism

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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;

  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

  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;

  4 months

Secondary Outcomes (13)

• Thermographic response

  3 months

• Indirect calorimetry

  3 months

• anthropometric measurements

  3 months

• Multifrequency bioimpedance

  3 months

• Dual x-ray absorptiometry

  3 months

Study Arms (3)

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.

Other: No intervention

Morning Physical Training

EXPERIMENTAL

Women who will perform the combined physical training at morning from 7 am to 10 am.

Behavioral: Morning Physical Training

Night Physical Training

EXPERIMENTAL

Women who will perform the combined physical training at night from 6 pm to 9 pm.

Behavioral: Night Physical Training

Interventions

Morning Physical Training BEHAVIORAL

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.

Morning Physical Training

Night Physical Training BEHAVIORAL

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.

Night Physical Training

No intervention OTHER

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.

Control

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• drug weight loss treatments
• previous bariatric surgery
• illness during the project period
• night shift workers
• attendance of 90% of the intervention with physical training

Sponsors & Collaborators

• State University of Minas Gerais: lead
• Federal University of Minas Gerais: collaborator
• University of Sao Paulo: collaborator
• Federal University of Uberlandia: collaborator

Study Sites (1)

Laboratory of Research Metabolism, Physiology and Exercise

Divinópolis, Minas Gerais, 35500010, Brazil

Location

Related Publications (21)

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  BACKGROUND

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• 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.

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• Tabela Brasileira de Composição de Alimentos - TACO

  BACKGROUND

• 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.

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• 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.

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• 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.

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• UCP2 expression is negatively correlated with and body fat mass after combined physical training: a pilot study

  BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Obesity; Overweight; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Using the randomization function of Microsoft Excel software, participants (n = 60) will be allocated into 3 experimental groups.

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion: December 20, 2024
• Study Completion: July 31, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-09

Locations

BR (1)