Metabolism of Obese Women Under Exercise and Recovery Hypoxia

Obesity Clinical Trial

Official title:

Metabolic Alterations in Obese Women Undergoing High-intensity Physical Exercise Associated With Intermittent Recovery Hypoxia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380830
• Other study ID #: DWR_Hypoxia
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obesity is characterized as a low-grade systemic inflammatory disease, which changes several pro-and anti-inflammatory cytokines. The practice of physical activity is a non-pharmacological method that results in the reduction of the systemic inflammatory state and, when associated with hypoxia exposure, may substantially improve this state. Deep-water running is highly indicated to obese for guarantee less joint impact and lower fatigue levels. In this way, the high-intensity exercise associated with intermittent recovery hypoxia in obese women will be investigated.

Description:

Obesity is characterized as a low-grade systemic inflammatory disease. With the increase in adipose tissue, several cytokines show alterations in synthesis and secretion, resulting in endocrine imbalances. The cytokines that most influence this process are adiponectin, which is anti-inflammatory and reduces its concentration during obesity. At the same time, the pro-inflammatory cytokines are tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6), which show a significant increase in the face of obesity. The practice of physical activity is a non-pharmacological method that results in the reduction of the systemic inflammatory state, altering the lipid profile and levels of both anti- and pro-inflammatory cytokines and the improvement of the individual's physical capacity. Due to the high joint overload and muscle stress, water exercises are recommended for obese individuals as it maintains motor stimulation with a low risk of injury. The training tied to running in a deep pool, also known as Deep Water Running (DWR), will promote advantages similar to running on the ground, such as improving aerobic capacity, avoiding impact and enabling the performance of exercise at high intensities lower levels of fatigue. The high-intensity exercise performance reduces the availability of oxygen to muscle cells, inducing the hypoxic environment, which causes stabilization of the hypoxia inductive factor 1 (HIF-1), promoting gene transcriptions related to erythropoiesis and angiogenesis. Thus, the present study aims to investigate the effects of high-intensity physical exercise associated with recovery hypoxia, observing both the inflammatory and lipid profile and the physical capacity of obese women grade I. For this, 45 women with obesity will participate in the study, divided into 3 groups: hypoxia, normoxia and control. All will perform body composition, food intake, hematological and lipid profile tests, plus the serum quantification of cytokines before and after the 8 weeks of physical training. Deep-water tied running (DWR) training will be periodized, high-intensity interval, with recovery in hypoxia or normoxia. Intermittent recovery hypoxia is expected to act as an additive effect on the use of oxygen by the muscle, resulting in an improvement in the hematological and lipid profile, aerobic capacity and changes in the inflammatory profile in obese women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 1, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women
• Age between 25 - 45 years old;
• BMI between 30 - 35kg/m²;
• Not be on a diet;
• Not be on a physical activity program;
• Not be menopaused.

Exclusion Criteria:

• Smokers;
• Alcoholics;
• Use thyroid medication;
• Carry out nutritional monitoring or in treatment for weight loss;
• Hypertension;
• Metabolical syndrome;
• Have any comorbidity associated to obesity;
• Drugs use.

Related Conditions & MeSH terms

• Hypoxia
• Obesity

Intervention

Other:
• Tied deep-Water Running
4 efforts of tied deep-water running for 5 minutes at 100-110%Vo2max under normoxia with 5 minutes of passive rest under hypoxia (FiO2=13%) or normoxia (FiO2= 20%). Frequency: 3x/week for 8 weeks.

Locations

Country	Name	City	State
Brazil	University of São Paulo, School of Physical Education and Sports of Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight changes (Anthropometry)	Changes in body weight (kilograms - Kg) pre- and post- intervention.	Eight weeks
Primary	Height assessment (Anthropometry)	Height measured in meters	Eight weeks
Primary	Body mass index changes (Anthropometry)	Changes in body mass index (BMI = weight measured(kg) / (height (m)²) evaluated pre- and post- intervention.	Eight weeks
Primary	Body composition changes (Anthropometry)	Changes in fat-free mass, fat mass and bone mineral content evaluated pre- and post- intervention. Dual energy x-ray absorptiometry (DEXA) will be use.	Eight weeks
Primary	Erythrogram (Hematological profile)	The red cells, hematocrit cells and hemoglobin will be evaluated pré- and post- intervention using a Radiometer-ABL 700 (Radiometer, Copenhagen, Denmark), and for erythropoietin evaluation an EPO Immunoassay ELISA kit will be used.	Eight weeks
Primary	EPO (Hematological profile)	The erythropoietin will be evaluated with an EPO Immunoassay ELISA kit in pre- and post- intervention .	Eight weeks
Primary	Lipid profile	Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol and blood glucose evaluated pre- and post- intervention, quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer.	Eight weeks
Primary	Inflammatory profile	Changes in serum levels of cytokines IL-6, TNF-a, adiponectin, FBP4 and leptin will be evaluated pre- and post- intervention, by MILLIPLEX® Kit.	Eight weeks
Primary	Changes in aerobic performance (deep-water running)	Physical tests performed pre-, after 4 weeks and post- intervention to assess aerobic physical fitness by incremental test in treadmill. The test aim to evaluate the anaerobic threshold (AT) and VO2peak in deep-water running.	eight weeks
Primary	Changes in aerobic performance (treadmill)	Physical tests performed pre-, after 4 weeks and post- intervention to assess aerobic physical fitness by incremental test in treadmill. The test aim to evaluate the anaerobic threshold (AT) and VO2peak in treadmill.	eight weeks
Primary	Food Intake changes	A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last eight weeks. The caloric intake, macronutrients and fiber will be evaluated over the intervention with Dietwin® software (São Paulo, Brazil).	Eight weeks
Primary	Processed and ultraprocessed food intake changes	The feed will undergo analysis through the NOVA Classification. By NOVA, food will be classified into four groups: Group 1 - Unprocessed or minimally processed foods; Group 2 - Processed culinary ingredients; Group 3 - Processed foods; Group 4 - Ultra-processed foods. For each category, the total calories ingested will be calculated, and later, represented in percentage (%) the participation of each food group in the general diet.	Eight weeks
Secondary	Rate of Perceived Effort (RPE)	The rate of perceived effort (RPE) will be noted after each effort during all the training program. The Borg scale will be used.	eight weeks
Secondary	Oxygen saturation (SpO2)	For group hypoxia and normoxia the oxigen saturation will be followed during the rest with a pulse oximeter. The SpO2 will be noted after the end of the effort, after 2,5 minutes in rest and in the end of the rest.	Eight weeks
Secondary	Internal load (TRIMP)	The .internal load will be calculated using TRIMP, that is calculated multipling the RPE for the time in effort (TRIMP = RPE * time in effort), for each participant and training session.	Eight weeks