ObesityNCT05380830
Metabolism of Obese Women Under Exercise and Recovery Hypoxia
A study testing Tied deep-Water Running in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Tied deep-Water Running
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2022to 1 Aug 2022
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Metabolic Alterations in Obese Women Undergoing High-intensity Physical Exercise Associated With Intermittent Recovery Hypoxia.
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Tied deep-Water Running
- Keywords
- Obesity, Intermittent hypoxia, Metabolic disease, Deep-water running
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tied deep-Water RunningOther
Also called DWR
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Group Hypoxia | Experimental | 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%). Receives: Other: Tied deep-Water Running |
| Group Normoxia | Placebo comparator | 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%). Receives: Other: Tied deep-Water Running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes (Anthropometry)
Changes in body weight (kilograms - Kg) pre- and post- intervention.
Measured: Eight weeks
Height assessment (Anthropometry)
Height measured in meters
Measured: Eight weeks
Body mass index changes (Anthropometry)
Changes in body mass index (BMI = weight measured(kg) / (height (m)²) evaluated pre- and post- intervention.
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
EPO (Hematological profile)
The erythropoietin will be evaluated with an EPO Immunoassay ELISA kit in pre- and post- intervention .
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: eight weeks
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.
Measured: eight weeks
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).
Measured: Eight weeks
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.
Measured: Eight weeks
Secondary outcomes (3)
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.
Measured: eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Mar 2022
- Primary completion10 May 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
- Investigators
- Marcela C Lima Viliod, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380830
- Sponsor's protocol ID
- DWR_Hypoxia
- Status last verified
- May 2023
- First submitted
- 7 May 2022
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Alterations in Obese Women Undergoing High-intensity Physical Exercise Associated With Intermittent Recovery Hypoxia.
- ClinicalTrials.gov ID
- NCT05380830
- Acronym / sponsor ID
- DWR_Hypoxia
- Conditions
- Obesity
- Keywords
- Obesity, Intermittent hypoxia, Metabolic disease, Deep-water running
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 19 May 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Group Hypoxia | Experimental | Other: Tied deep-Water RunningDuring 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%). |
| Group Normoxia | Placebo comparator | Other: Tied deep-Water RunningDuring 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%). |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women
- Age between 25 - 45 years old;
- BMI between 30 - 35kg/m²;
- Not be on a diet;
- Not be on a physical activity program;
Key exclusion criteria (8 listed)
- Smokers;
- Alcoholics;
- Use thyroid medication;
- Carry out nutritional monitoring or in treatment for weight loss;
- Hypertension;
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 |
|---|---|---|
| Tied deep-Water RunningAlso: DWR4 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. | Other | Group Hypoxia, Group Normoxia |
Primary outcome
Body weight changes (Anthropometry)
Time frame: Eight weeks
Changes in body weight (kilograms - Kg) pre- and post- intervention.
Height assessment (Anthropometry)
Time frame: Eight weeks
Height measured in meters
Body mass index changes (Anthropometry)
Time frame: Eight weeks
Changes in body mass index (BMI = weight measured(kg) / (height (m)²) evaluated pre- and post- intervention.
Body composition changes (Anthropometry)
Time frame: Eight weeks
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)
Time frame: Eight weeks
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)
Time frame: Eight weeks
The erythropoietin will be evaluated with an EPO Immunoassay ELISA kit in pre- and post- intervention .
Lipid profile
Time frame: Eight weeks
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
Time frame: Eight weeks
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)
Time frame: eight weeks
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)
Time frame: eight weeks
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
Time frame: Eight weeks
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
Time frame: Eight weeks
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.
3 secondary outcomes
Rate of Perceived Effort (RPE)
Time frame: eight weeks
Oxygen saturation (SpO2)
Time frame: Eight weeks
Internal load (TRIMP)
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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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.
Marcela C Lima Viliod principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tied deep-Water Running in people with Obesity, run by University of Sao Paulo 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 15 May 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body weight changes (Anthropometry) (time frame: Eight weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.