Overweight and ObesityNCT03568773
Influence of Genetic and Physiological in Weight Loss
A study testing High-intensity interval training and Aerobic exercise moderate intensity in people with Overweight and Obesity and Chronic Disease, run by Federal University of Paraíba.
Trial summary
The study focuses on the influence of polymorphism in the FTO genes rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by HIIT and continuous aerobic programs in obese or overweight individuals. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Chronic Disease
- What is being tested?
- High-intensity interval training and Aerobic exercise moderate intensity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2016to 15 Nov 2018
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 20-45 years;
- Were insufficiently active for at least six months prior to recruitment as determined by the International Physical Activity Questionnaire (IPAQ) (<150 minutes of moderate to intense physical activity / week) (MATSUDO, 2001);
- Were overweight or obese (BMI between 25kg / m2 and 39.9kg / m2) (WHO, 2015);
- Did not suffer any change in weight (more than 5kg in the last three months);
- Do not be smokers or acololistas (maximum of 2 doses / day);
- They may not be users of supplements and / or medications that influence weight loss or weight gain;
Show all 9Show fewer
- No history of coronary, respiratory, metabolic, or musculoskeletal disease affecting ability to participate in the training program;
- Have been considered fit in an exercise test performed immediately prior to physical intervention;
- Women are not menopausal (menstrual cycle stopped more than one year) or have symptoms related to the climacteric phase.
Who cannot join
- Individuals who lack at least 25% of the total training program or two consecutive weeks;
- Initiate medication treatment, supplementation, diet and / or other physical training program during the intervention period;
- During training, osseous and / or myoarticular lesions that affect the ability to continue participating in the intervention.
About this study
Official title: Influence of Polymorphysms in the Fto and Ppar Gen Genes, Systemic Inflammation and Oxidative Stress in the Magnitude of Weight Loss Induced by Intermittent or Moderate Continuous High Intensity Training Programs
The study focuses on the influence of polymorphism in the FTO genes rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by HIIT and continuous aerobic programs in obese or overweight individuals.
Read the detailed description
Although the positive effects of continuous aerobic training are already well documented in the literature on health aspects. The weight loss induced by physical training is still very discrete when compared to other antiobesity means. Studies demonstrate an important variability in responses to physical exercise, indicating that individuals respond more or less to weight loss. Among these aspects, the factors that may influence exercise-induced weight loss have not yet been elucidated. Thus, the objective of the study is to analyze the influence of polymorphism in the genes FTO rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by continuous and continuous aerobic programs. Healthy individuals with overweight and / or obesity, aged 20-45 years, were randomly assigned to three groups: Continuous Aerobic (AC), Intermittent High Intensity Training (HIIT) and Control Group (CG). Groups (AC) and (HIIT) engaged in a 12-week program. Before the start of the program, at the sixth week and 48 hours after the intervention, they performed blood collections, ergospirometry, dual X-ray densitometry (DEXA), nutritional assessments. In addition, collection of buccal mucosa was performed for genotyping of polymorphisms studied. Initial differences between the groups, as well as between the dependent variables studied will be assessed using the two-way ANOVA test or its non-parametric equivalent. Correlation and regression tests will be performed to verify the influence of the independent variables and the magnitude of the exercise-induced weight loss, according to the normality of the data or differences between the standard deviations. The hypothesis tested is that genetic and physiological factors influence the weight loss independent of the training modality.
- Conditions
- Overweight and Obesity, Chronic Disease
- Being tested
- High-intensity interval training, Aerobic exercise moderate intensity, Control Group
- Medical subject headings
- Overweight, Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
HIIT training is being conducted on a three-day weekly frequency on a stationary bike. The protocol consisted of two weeks of adaptation with 12 weeks of training that alternated between sprints ranging from 30 s to 60 s (> 95% VO2max), and active recovery ranging from 180 s to 120 s (30 W on the bicycle).
Aerobic exercise moderate intensityOther
The aerobic training is performed in a walking or running mode, with three weeks of adaptation (2x / wk - 20 to 30 minutes / session, <threshold 1) and 12 weeks of training (3 to 5x / wk - 40 to 60 minutes / session, with prescribed intensities between the anaerobic threshold - L1 and the respiratory compensation point - L2).
Control GroupOther
The control group is participating in lengthening classes to increase the adherence and control of the influencing variables. Classes are being held once a week for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | The HIIT protocol is being performed with the cycling mode. The program consists of repeated intense explosions alternating with recovery intervals.
The adaptation period consists of 4 shots of 20 seconds interspersed by 180 seconds interval (active recovery). From the first to the fourth week the volunteers performed from four to six race shots from 30 to 45s with intervals from 180s to 120s. From the fifth week until the end of the intervention, training takes place with six shots of 60s with a 120s interval between running shots. The work intensity for all sessions is above 95% of VO2max, with 30W of recovery. In addition, participants refer to number 19 on the Borg Scale. Sessions range from 12 to 36 minutes without heating and recovery. In total there are 12 weeks of training. Receives: Other: High-intensity interval training |
| Aerobic exercise moderate intensity | Experimental | The training protocol was started, with the sessions held in the open air. From the first to the fourth week, the volunteers gave sessions of 40 to 60 minutes, intensity in L1, three sessions / week. In the fifth week, the intensity was increased to the midpoint between L1 and half of L2, maintaining 60 minutes per session and frequency three times per week. From the sixth week, the weekly frequency increased to five days, with three supervised sessions and two unsupervised sessions, but with a smartphone application that recorded distance traveled and intensity. From the ninth week on, the weekly frequency was maintained and the intensity increased for L2. In supervised sessions, training intensity is also monitored by heart rate using a Polar heart rate monitor. Receives: Other: Aerobic exercise moderate intensity |
| Control Group | Experimental | The control group attends stretching classes once a week and sessions lasting 60 minutes. At the end of the fifteen weeks (three weeks of adaptation and twelve weeks of training) of the study, these volunteers will be invited to engage in the aerobic training program regardless of their participation in the research. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition. The changes are being evaluated.
The procedure used for analysis is done using a Dual Energy Radiological Absortiometry (DEXA) equipment. The measurement of the body fat and fat free mass percentage measure is obtained by means of a full body scan using the LUNAR PRODIGY DF + 14.319 Radiation (Madison, WI) brand device, following manufacturer's protocols. The body mass is evaluated by means of a balance (Sanny®, São Bernardo do Campo - São Paulo, Brazil), with the volunteer barefoot and in orthostatic position using a Toledo scale sensitive to 100 g. The stature is evaluated by a stadiometer with a tape calibrated at 0.1 of the same mark. Waist circumference and other body perimeters are measured with a 0.1 cm Anthropometric Tape (Sanny®, São Bernardo do Campo - São Paulo, Brazil). Weight and height data are used to calculate BMI using the equation adopted by the WHO: BMI = (Weight / (Stature) 2).
Measured: Before the intervention protocol and 48 hours immediately after the last exercise session.
Secondary outcomes (7)
Metabolic Rate of Rest. The changes are being evaluated.
The metabolic rate was measured using a gas spirometry analyzer. After having fasted from 8:00 pm the previous day, the volunteers were referred to the laboratory shortly after the awakening and were invited to remain seated in a thermoneutral environment for 30 minutes. For the next 30 minutes, VO2, VCO2, VE and RER were monitored until variations of no more than 10% occurred when five-minute intervals were compared. Once this steady state was obtained, these variables were recorded for five minutes. The calculation of the resting metabolic rate is done according to Macdonald (1990).
Measured: Before the intervention protocol and 48 hours immediately after the last exercise session.
Lipid and Glycemic Profile. The changes are being evaluated.
Collections of 10 ml of blood from the antecubital vein will be performed early in the morning, with fasting from 10 to 12 hours. The collections will be done 24 hours before, in the 6th week and after the intervention period. They will remain seated for 10 minutes for subsequent collection. Five milliliters of blood will be placed in EDTA-containing test tubes, protected from light and gently homogenized by inversion. The other 5ml will be placed in tubes without anticoagulants. They will then be centrifuged at 3,000 rpm for 10 min. The plasma or serum will be separated, placed in eppendorf tubes and refrigerated at -20 ° C until analysis. All analyzes will be carried out using a commercial kit of the Labtest brand (Minas Gerais-Brazil). The analyzes will be carried out on serum samples using commercial Labtest kits (Minas Gerais, Brazil), following the manufacturer's recommendations and on a Labmax 240 premium automatic analyzer (Lagoa Santa-MG, Brazil).
Measured: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Oxidative stress (Malondialdehyde). The changes are being evaluated.
10 ml of blood will be collected in the beginning of the morning, with fasting of 10 to 12 hours, being done 24 hours before, in the 6th week and after the intervention period. Five milliliters of blood will be placed in test tubes containing EDTA and protected from light and the other 5ml will be placed in tubes without anticoagulants and centrifuged at 3,000 rpm for 10 min. The plasma or serum will be separated, placed in eppendorf tubes and refrigerated at -20 ° C until analyzed by a commercial kit of the Labtest brand (Minas Gerais, Brazil). For this, 250 μl of sample will be added to KCl and incubated in a water bath (37 ° / 60 minutes). The mixture will be precipitated with 35% AA perchloric acid and centrifuged at 14,000 rpm for 10 minutes at 4 ° C. The supernatant will be transferred to eppendorfs and 400μl of 0.6% thiobarbituric acid is added and incubated at 95-100 ° C for 30minutes. The material will be read in a spectrophotometer at a wavelength of 532nm.
Measured: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Oxidative stress (Total antioxidant capacity). The changes are being evaluated.
10 ml of blood will be collected in the beginning of the morning, with fasting of 10 to 12 hours, being done 24 hours before, in the 6th week and after the intervention period. Five milliliters of blood will be placed in test tubes containing EDTA and protected from light and the other 5ml will be placed in tubes without anticoagulants and centrifuged at 3,000 rpm for 10 min. The plasma or serum will be separated, placed in eppendorf tubes and refrigerated at -20 ° C until analyzed by a commercial kit of the Labtest brand (Minas Gerais, Brazil). The evaluation of the total antioxidant capacity will be performed through DPPH. For analysis, 100 μl of plasma will be added to 3.9 ml of vortexed DPPH solution, set to stand for 30 minutes and then centrifuged at 10,000 rpm for 15 minutes at 20 ° C. The supernatant will be used for spectrophotometer reading at 515 nm wavelength, using distilled white water. The result will be expressed as a percentage of antioxidant activity.
Measured: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Systemic Inflammation (Plasma ultra-sensitive C-reactive protein). The changes are being evaluated.
10 ml of blood will be collected in the beginning of the morning, with fasting of 10 to 12 hours, being done 24 hours before, in the 6th week and after the intervention period. Five milliliters of blood will be placed in test tubes containing EDTA and protected from light and the other 5ml will be placed in tubes without anticoagulants and centrifuged at 3,000 rpm for 10 min. The plasma or serum will be separated, placed in eppendorf tubes and refrigerated at -20 ° C until analyzed by a commercial kit of the Labtest brand (Minas Gerais, Brazil). The concentration of hs-CRP will be quantified by immunoturbidimetry in serum samples. Calibration will use the Calibra Calibrator from Labtest (Calibra Plus PCR-ultra - Ref-345). Absorbance will be obtained on the Labmax 240 premium automatic analyzer at 540 nm wavelength. The concentrations of hs-CRP will be determined by the commercial kit (Labtest, Minas Gerais, Brazil) according to the manufacturer's instructions.
Measured: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Systemic Inflammation (Analysis of alpha-1-glycoprotein acid). The changes are being evaluated.
10 ml of blood will be collected in the beginning of the morning, with fasting of 10 to 12 hours, being done 24 hours before, in the 6th week and after the intervention period. Five milliliters of blood will be placed in test tubes containing EDTA and protected from light and the other 5ml will be placed in tubes without anticoagulants and centrifuged at 3,000 rpm for 10 min. The plasma or serum will be separated, placed in eppendorf tubes and refrigerated at -20 ° C until analyzed by a commercial kit of the Labtest brand (Minas Gerais, Brazil). The A1GPA concentration will be quantified by immunoturbidimetry using the commercial kit (Labtest, Minas Gerais, Brazil) as per manufacturer's instructions. Calibration will use the Calibra Calibrator from Labtest (Calibra Plus Protein - Ref-346). The absorbance will be obtained in the Labmax 240 premium automatic analyzer (Lagoa Santa-MG, Brazil), at wavelength 340nm.
Measured: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
DNA Extraction and Genotyping
Oral cell samples were collected through a mouthwash for 60 seconds of 5 ml of 3% sucrose solution. The resulting contents of the mouthwash were transferred to a 15 ml tube, which immediately afterwards was placed in a solution of TNE (17 mM Tris-HCl pH 8.0, 50 mM NaCl and 7 mM EDTA), diluted to 66% alcohol and autoclaved distilled water.After this, the extraction and genotyping process followed the recommendations of Saiki et al. (1985)
Measured: The genetic collection will be made in the 6th week of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start10 Mar 2016
- Primary completion12 Oct 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Experimental, controlled and randomized study.
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Suelen Brito da Silva, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568773
- Sponsor's protocol ID
- FUP
- Status last verified
- Jul 2020
- First submitted
- 3 May 2018
- Last updated
- 31 Jul 2020
- 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 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Polymorphysms in the Fto and Ppar Gen Genes, Systemic Inflammation and Oxidative Stress in the Magnitude of Weight Loss Induced by Intermittent or Moderate Continuous High Intensity Training Programs
- ClinicalTrials.gov ID
- NCT03568773
- Acronym / sponsor ID
- FUP
- Conditions
- Overweight and Obesity, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 26 Jun 2018 (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.
The study focuses on the influence of polymorphism in the FTO genes rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by HIIT and continuous aerobic programs in obese or overweight individuals.
Detailed description
Although the positive effects of continuous aerobic training are already well documented in the literature on health aspects. The weight loss induced by physical training is still very discrete when compared to other antiobesity means. Studies demonstrate an important variability in responses to physical exercise, indicating that individuals respond more or less to weight loss. Among these aspects, the factors that may influence exercise-induced weight loss have not yet been elucidated. Thus, the objective of the study is to analyze the influence of polymorphism in the genes FTO rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by continuous and continuous aerobic programs. Healthy individuals with overweight and / or obesity, aged 20-45 years, were randomly assigned to three groups: Continuous Aerobic (AC), Intermittent High Intensity Training (HIIT) and Control Group (CG). Groups (AC) and (HIIT) engaged in a 12-week program. Before the start of the program, at the sixth week and 48 hours after the intervention, they performed blood collections, ergospirometry, dual X-ray densitometry (DEXA), nutritional assessments. In addition, collection of buccal mucosa was performed for genotyping of polymorphisms studied. Initial differences between the groups, as well as between the dependent variables studied will be assessed using the two-way ANOVA test or its non-parametric equivalent. Correlation and regression tests will be performed to verify the influence of the independent variables and the magnitude of the exercise-induced weight loss, according to the normality of the data or differences between the standard deviations. The hypothesis tested is that genetic and physiological factors influence the weight loss independent of the training modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental, controlled and randomized study.
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Other: High-intensity interval trainingThe HIIT protocol is being performed with the cycling mode. The program consists of repeated intense explosions alternating with recovery intervals. The adaptation period consists of 4 shots of 20 seconds interspersed by 180 seconds interval (active recovery). From the first to the fourth week the volunteers performed from four to six race shots from 30 to 45s with intervals from 180s to 120s. From the fifth week until the end of the intervention, training takes place with six shots of 60s with a 120s interval between running shots. The work intensity for all sessions is above 95% of VO2max, with 30W of recovery. In addition, participants refer to number 19 on the Borg Scale. Sessions range from 12 to 36 minutes without heating and recovery. In total there are 12 weeks of training. |
| Aerobic exercise moderate intensity | Experimental | Other: Aerobic exercise moderate intensityThe training protocol was started, with the sessions held in the open air. From the first to the fourth week, the volunteers gave sessions of 40 to 60 minutes, intensity in L1, three sessions / week. In the fifth week, the intensity was increased to the midpoint between L1 and half of L2, maintaining 60 minutes per session and frequency three times per week. From the sixth week, the weekly frequency increased to five days, with three supervised sessions and two unsupervised sessions, but with a smartphone application that recorded distance traveled and intensity. From the ninth week on, the weekly frequency was maintained and the intensity increased for L2. In supervised sessions, training intensity is also monitored by heart rate using a Polar heart rate monitor. |
| Control Group | Experimental | Other: Control GroupThe control group attends stretching classes once a week and sessions lasting 60 minutes. At the end of the fifteen weeks (three weeks of adaptation and twelve weeks of training) of the study, these volunteers will be invited to engage in the aerobic training program regardless of their participation in the research. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and women aged 20-45 years;
- Were insufficiently active for at least six months prior to recruitment as determined by the International Physical Activity Questionnaire (IPAQ) (<150 minutes of moderate to intense physical activity / week) (MATSUDO, 2001);
- Were overweight or obese (BMI between 25kg / m2 and 39.9kg / m2) (WHO, 2015);
- Did not suffer any change in weight (more than 5kg in the last three months);
- Do not be smokers or acololistas (maximum of 2 doses / day);
Key exclusion criteria (3 listed)
- Individuals who lack at least 25% of the total training program or two consecutive weeks;
- Initiate medication treatment, supplementation, diet and / or other physical training program during the intervention period;
- During training, osseous and / or myoarticular lesions that affect the ability to continue participating in the intervention.
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 |
|---|---|---|
| High-intensity interval trainingHIIT training is being conducted on a three-day weekly frequency on a stationary bike. The protocol consisted of two weeks of adaptation with 12 weeks of training that alternated between sprints ranging from 30 s to 60 s (> 95% VO2max), and active recovery ranging from 180 s to 120 s (30 W on the bicycle). | Other | High-intensity interval training |
| Aerobic exercise moderate intensityThe aerobic training is performed in a walking or running mode, with three weeks of adaptation (2x / wk - 20 to 30 minutes / session, <threshold 1) and 12 weeks of training (3 to 5x / wk - 40 to 60 minutes / session, with prescribed intensities between the anaerobic threshold - L1 and the respiratory compensation point - L2). | Other | Aerobic exercise moderate intensity |
| Control GroupThe control group is participating in lengthening classes to increase the adherence and control of the influencing variables. Classes are being held once a week for 60 minutes. | Other | Control Group |
Primary outcome
Body Composition. The changes are being evaluated.
Time frame: Before the intervention protocol and 48 hours immediately after the last exercise session.
The procedure used for analysis is done using a Dual Energy Radiological Absortiometry (DEXA) equipment. The measurement of the body fat and fat free mass percentage measure is obtained by means of a full body scan using the LUNAR PRODIGY DF + 14.319 Radiation (Madison, WI) brand device, following manufacturer's protocols. The body mass is evaluated by means of a balance (Sanny®, São Bernardo do Campo - São Paulo, Brazil), with the volunteer barefoot and in orthostatic position using a Toledo scale sensitive to 100 g. The stature is evaluated by a stadiometer with a tape calibrated at 0.1 of the same mark. Waist circumference and other body perimeters are measured with a 0.1 cm Anthropometric Tape (Sanny®, São Bernardo do Campo - São Paulo, Brazil). Weight and height data are used to calculate BMI using the equation adopted by the WHO: BMI = (Weight / (Stature) 2).
7 secondary outcomes
Metabolic Rate of Rest. The changes are being evaluated.
Time frame: Before the intervention protocol and 48 hours immediately after the last exercise session.
Lipid and Glycemic Profile. The changes are being evaluated.
Time frame: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Oxidative stress (Malondialdehyde). The changes are being evaluated.
Time frame: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Oxidative stress (Total antioxidant capacity). The changes are being evaluated.
Time frame: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Systemic Inflammation (Plasma ultra-sensitive C-reactive protein). The changes are being evaluated.
Time frame: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
Systemic Inflammation (Analysis of alpha-1-glycoprotein acid). The changes are being evaluated.
Time frame: The collections will be done 24 hours before, in the 6th week and 48 hours after the end of the intervention.
DNA Extraction and Genotyping
Time frame: The genetic collection will be made in the 6th week of the intervention.
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 31 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Aerobic exercise moderate intensity in people with Overweight and Obesity and Chronic Disease, run by Federal University of Paraíba.
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 9 inclusion and 3 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Composition. The changes are being evaluated. (time frame: Before the intervention protocol and 48 hours immediately after the last exercise session.). 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 31 Jul 2020.