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Metabolism of Obese Women Under Exercise and Recovery Hypoxia

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tied deep-Water Running
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Intermittent hypoxia, Metabolic disease, Deep-water running

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of São Paulo, School of Physical Education and Sports of Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Placebo Comparator

Arm Label

Control

Group Hypoxia

Group Normoxia

Arm Description

The group will be only submitted to evaluations (body composition, hematological, lipid and cytokines profile, food intake, and maximal effort under treadmill and deep-water running) at the beginning and the end of the study.

During the intervention of 8 weeks the participants will have the deep-water running training under normoxia, but during the rest they will be under hypoxia (FiO2=13%).

During the intervention of 8 weeks the participants will have the deep-water running training under normoxia, and during the rest they will keep under normoxia (FiO2=20%).

Outcomes

Primary Outcome Measures

Body weight changes (Anthropometry)
Changes in body weight (kilograms - Kg) pre- and post- intervention.
Height assessment (Anthropometry)
Height measured in meters
Body mass index changes (Anthropometry)
Changes in body mass index (BMI = weight measured(kg) / (height (m)²) evaluated pre- and post- intervention.
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.
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.
EPO (Hematological profile)
The erythropoietin will be evaluated with an EPO Immunoassay ELISA kit in pre- and post- intervention .
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.
Inflammatory profile
Changes in serum levels of cytokines IL-6, TNF-α, adiponectin, FBP4 and leptin will be evaluated pre- and post- intervention, by MILLIPLEX® Kit.
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.
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.
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).
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 7, 2022
Last Updated
May 12, 2023
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05380830
Brief Title
Metabolism of Obese Women Under Exercise and Recovery Hypoxia
Official Title
Metabolic Alterations in Obese Women Undergoing High-intensity Physical Exercise Associated With Intermittent Recovery Hypoxia.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Intermittent hypoxia, Metabolic disease, Deep-water running

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial.
Masking
Participant
Masking Description
Participants will be randomly distributed into 3 groups: Control (Gcon), Hypoxia (GHyp) and Normoxia (GNor). Those in Ghyp and GNor won't be able to know which group they are.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The group will be only submitted to evaluations (body composition, hematological, lipid and cytokines profile, food intake, and maximal effort under treadmill and deep-water running) at the beginning and the end of the study.
Arm Title
Group Hypoxia
Arm Type
Experimental
Arm Description
During the intervention of 8 weeks the participants will have the deep-water running training under normoxia, but during the rest they will be under hypoxia (FiO2=13%).
Arm Title
Group Normoxia
Arm Type
Placebo Comparator
Arm Description
During the intervention of 8 weeks the participants will have the deep-water running training under normoxia, and during the rest they will keep under normoxia (FiO2=20%).
Intervention Type
Other
Intervention Name(s)
Tied deep-Water Running
Other Intervention Name(s)
DWR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight changes (Anthropometry)
Description
Changes in body weight (kilograms - Kg) pre- and post- intervention.
Time Frame
Eight weeks
Title
Height assessment (Anthropometry)
Description
Height measured in meters
Time Frame
Eight weeks
Title
Body mass index changes (Anthropometry)
Description
Changes in body mass index (BMI = weight measured(kg) / (height (m)²) evaluated pre- and post- intervention.
Time Frame
Eight weeks
Title
Body composition changes (Anthropometry)
Description
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.
Time Frame
Eight weeks
Title
Erythrogram (Hematological profile)
Description
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.
Time Frame
Eight weeks
Title
EPO (Hematological profile)
Description
The erythropoietin will be evaluated with an EPO Immunoassay ELISA kit in pre- and post- intervention .
Time Frame
Eight weeks
Title
Lipid profile
Description
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.
Time Frame
Eight weeks
Title
Inflammatory profile
Description
Changes in serum levels of cytokines IL-6, TNF-α, adiponectin, FBP4 and leptin will be evaluated pre- and post- intervention, by MILLIPLEX® Kit.
Time Frame
Eight weeks
Title
Changes in aerobic performance (deep-water running)
Description
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.
Time Frame
eight weeks
Title
Changes in aerobic performance (treadmill)
Description
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.
Time Frame
eight weeks
Title
Food Intake changes
Description
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).
Time Frame
Eight weeks
Title
Processed and ultraprocessed food intake changes
Description
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.
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Rate of Perceived Effort (RPE)
Description
The rate of perceived effort (RPE) will be noted after each effort during all the training program. The Borg scale will be used.
Time Frame
eight weeks
Title
Oxygen saturation (SpO2)
Description
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.
Time Frame
Eight weeks
Title
Internal load (TRIMP)
Description
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.
Time Frame
Eight weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcela C Lima Viliod
Organizational Affiliation
USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabolism of Obese Women Under Exercise and Recovery Hypoxia

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