Metabolism DisorderNCT03119350
Mitochondrial Energy Metabolism in Obese Women
A study testing Physical Training in people with Metabolism Disorder and Mitochondrial Alteration, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Considering that the failure of the treatment of obesity is justified by the multifactorial pathophysiology of this morbidity, the present project has the following hypotheses: 1. The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ; 2. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Metabolism Disorder, Mitochondrial Alteration, Physical Activity
- What is being tested?
- Physical Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2016to 15 Sep 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- This study included women with obesity (BMI of 30 to 40 kg / m²), sedentary, with no associated comorbidity, convenience sample
Who cannot join
- Women who have undergone bariatric surgery, menopause, cancer or any metabolic disease, smokers, alcoholics, who are in use of drugs that act directly on the metabolism and that have medical impediment to the practice of physical exercise.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Camila Fernanda Cunha Brandão
Ribeirão Preto, São Paulo, 14.048-900
About this study
Official title: Mitochondrial Energy Metabolism in Obese Women Undergoing Concurrent Physical Training
Considering that the failure of the treatment of obesity is justified by the multifactorial pathophysiology of this morbidity, the present project has the following hypotheses:
- The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;
- The unbalance is therapeutically modified through physical training ;
- Obesity courses with the break-down in energy metabolism mitochondrial disease associated with systemic inflammatory characteristics that can be corrected through a combined long-term physical training program.
This study have as objective : to analyse changes in mitochondrial function, inflammatory profile, oxidative stress and energy metabolism caused by concurrent physical training in obese women.
Read the detailed description
Specific objectives:
Body composition by deuterium oxide; Metabolic rate of resting and oxidation of substrates by indirect calorimetry; Proinflammatory cytokines Anti-inflammatory cytokines Oxidative Stress: Malondialdehyde, Superoxide Dismutase, Glutathione-Peroxidase; Fatty acids: ceramide and palmitate; Mitochondrial respiration and citrate synthase enzyme; Quantify and qualify: mitochondrial number, endoplasmic reticulum structure, adipose cell size; Gene expression, quantify by microscopy and analyze the protein by western blot.
The study began with 20 women, however, there was withdrawal of 6, ending with 14 women.
- Being tested
- Physical Training
- Medical subject headings
- Metabolic Diseases, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TrainingOther
Intervention with concurrent physical training: strength and aerobic exercises in the same session.
Duration: 2 weeks of adaptation to physical exercise, 8 weeks of training. Frequency: 3 times a week. Time: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Physical Training | Other | There was concurrent physical training intervention: strength and aerobic exercises in the same session.
Duration: 2 weeks of adaptation and learning to exercise, 8 weeks of physical training.
Frequency: 3 times per week Duration: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate. Receives: Other: Physical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes Body weight
Body weight was measured by digital balance before and after the intervention
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Body composition
The change in body composition through deuterium oxide was evaluated.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes White adipose tissue biopsy
A subcutaneous tissue sample was collected for analysis of: mitochondrial respiration, citrate synthase enzyme, gene expression (UCP1, 2 and 3).
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Indirect calorimetry
With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (Lipids and carbohydrates).
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes in fatty acids
Collected in lithium heparin tubes, they were centrifuged.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes oxidative stress
Collected in lithium heparin tubes, they were centrifuged.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes inflammatory cytokines
Collected in lithium heparin tubes, they were centrifuged.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes in total cholesterol
Collected in lithium heparin tubes, they were centrifuged.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Physical Performance
Based on the Shuttle Walking Test adaptation.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes in Determination of Lactate
Blood samples were collected by manual puncture of the earlobe in previously calibrated and heparinized capillary tubes, stored in eppendorf with sodium fluoride. Analyzed by electrochemical lactate analyser.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Food intake
Food registry of 3 days, the quantification of the daily intake of nutrients will still be made using software.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Nitrogen Balance
Through the collection of urine of 24 hours the dosage of urinary nitrogen will be made by the chemiluminescence method for determination of protein nitrogen.
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Telomere length
peripheral blood in ethylenediaminetetraacetic acid tubes and genomic DNA was automatically extracted from Peripheral Blood Mononuclear Cell. The relative quantification of Telomere length was determined using the telomere to single copy gene ratio by Quantitative Polymerase Chain Reaction (qPCR).
Measured: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Apr 2016
- Primary completion1 Jul 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Metabolism DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Sergio Marchini, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119350
- Sponsor's protocol ID
- Process HCRP: 1.387.040/2016
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
BROWN, L.E.; WEIR, J.P.; ASEP procedures recommendation i: accurate assessment of muscular strength and power, Journal of Exercise Physiology, v. 4, n. 3, p. 1-21, 2001.
Burgomaster KA, Howarth KR, Phillips SM, Rakobowchuk M, Macdonald MJ, McGee SL, Gibala MJ. Similar metabolic adaptations during exercise after low volume sprint interval and traditional endurance training in humans. J Physiol. 2008 Jan 1;586(1):151-60. doi: 10.1113/jphysiol.2007.142109. Epub 2007 Nov 8.
PubMed 17991697Chomczynski P, Sacchi N. Single-step method of RNA isolation by acid guanidinium thiocyanate-phenol-chloroform extraction. Anal Biochem. 1987 Apr;162(1):156-9. doi: 10.1006/abio.1987.9999.
PubMed 2440339Colégio Americano de Medicina Esportiva, CAME. Guia para Teste de Esforço e Prescrição de Exercício. 3º Edição, Medsi, Rio de janeiro, RJ, p.25, 1987.
Crump C, Sundquist J, Winkleby MA, Sundquist K. Interactive effects of obesity and physical fitness on risk of ischemic heart disease. Int J Obes (Lond). 2017 Feb;41(2):255-261. doi: 10.1038/ijo.2016.209. Epub 2016 Nov 21.
PubMed 27867205Curtis JM, Grimsrud PA, Wright WS, Xu X, Foncea RE, Graham DW, Brestoff JR, Wiczer BM, Ilkayeva O, Cianflone K, Muoio DE, Arriaga EA, Bernlohr DA. Downregulation of adipose glutathione S-transferase A4 leads to increased protein carbonylation, oxidative stress, and mitochondrial dysfunction. Diabetes. 2010 May;59(5):1132-42. doi: 10.2337/db09-1105. Epub 2010 Feb 11.
PubMed 20150287Daussin FN, Zoll J, Dufour SP, Ponsot E, Lonsdorfer-Wolf E, Doutreleau S, Mettauer B, Piquard F, Geny B, Richard R. Effect of interval versus continuous training on cardiorespiratory and mitochondrial functions: relationship to aerobic performance improvements in sedentary subjects. Am J Physiol Regul Integr Comp Physiol. 2008 Jul;295(1):R264-72. doi: 10.1152/ajpregu.00875.2007. Epub 2008 Apr 16.
PubMed 18417645EIGENTLER, A.; DRAXL, A.; et al. Laboratory Protocol: Citrate synthase a mitochondrial marker enzyme. Mitochondrial Physiology Network, v. 17.04, n. 3, p. 1-11, 2015.
Fernstrom M, Bakkman L, Loogna P, Rooyackers O, Svensson M, Jakobsson T, Brandt L, Lagerros YT. Improved Muscle Mitochondrial Capacity Following Gastric Bypass Surgery in Obese Subjects. Obes Surg. 2016 Jul;26(7):1391-7. doi: 10.1007/s11695-015-1932-z.
PubMed 26471784Ferreira FC, Bertucci DR, Barbosa MR, Nunes JE, Botero JP, Rodrigues MF, Shiguemoto GE, Santoro V, Verzola AC, Nonaka RO, Verzola RM, Baldissera V, Perez SE. Circuit resistance training in women with normal weight obesity syndrome: body composition, cardiometabolic and echocardiographic parameters, and cardiovascular and skeletal muscle fitness. J Sports Med Phys Fitness. 2017 Jul-Aug;57(7-8):1033-1044. doi: 10.23736/S0022-4707.16.06391-X. Epub 2016 Jul 6.
PubMed 27385544FETT, C.A.; FETT, W.C.R.; MARCHINI, J.S. Fitness Level of Overweight/Obese Women After 08 Weeks of Aerobic or Mixed Metabolism Exercises. Revista Brasileira de Cineantropometria & Desempenho Humano, v. 11, p. 261-266, 2009.
Foster C. Monitoring training in athletes with reference to overtraining syndrome. Med Sci Sports Exerc. 1998 Jul;30(7):1164-8. doi: 10.1097/00005768-199807000-00023.
PubMed 9662690Frayn KN. Calculation of substrate oxidation rates in vivo from gaseous exchange. J Appl Physiol Respir Environ Exerc Physiol. 1983 Aug;55(2):628-34. doi: 10.1152/jappl.1983.55.2.628.
PubMed 6618956Grimble GK, West MF, Acuti AB, Rees RG, Hunjan MK, Webster JD, Frost PG, Silk DB. Assessment of an automated chemiluminescence nitrogen analyzer for routine use in clinical nutrition. JPEN J Parenter Enteral Nutr. 1988 Jan-Feb;12(1):100-6. doi: 10.1177/0148607188012001100.
PubMed 3125351Heilbronn LK, Gan SK, Turner N, Campbell LV, Chisholm DJ. Markers of mitochondrial biogenesis and metabolism are lower in overweight and obese insulin-resistant subjects. J Clin Endocrinol Metab. 2007 Apr;92(4):1467-73. doi: 10.1210/jc.2006-2210. Epub 2007 Jan 23.
PubMed 17244782
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Energy Metabolism in Obese Women Undergoing Concurrent Physical Training
- ClinicalTrials.gov ID
- NCT03119350
- Acronym / sponsor ID
- Process HCRP: 1.387.040/2016
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 18 Apr 2017 (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.
Considering that the failure of the treatment of obesity is justified by the multifactorial pathophysiology of this morbidity, the present project has the following hypotheses:
- The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;
- The unbalance is therapeutically modified through physical training ;
- Obesity courses with the break-down in energy metabolism mitochondrial disease associated with systemic inflammatory characteristics that can be corrected through a combined long-term physical training program.
This study have as objective : to analyse changes in mitochondrial function, inflammatory profile, oxidative stress and energy metabolism caused by concurrent physical training in obese women.
Detailed description
Specific objectives:
Body composition by deuterium oxide; Metabolic rate of resting and oxidation of substrates by indirect calorimetry; Proinflammatory cytokines Anti-inflammatory cytokines Oxidative Stress: Malondialdehyde, Superoxide Dismutase, Glutathione-Peroxidase; Fatty acids: ceramide and palmitate; Mitochondrial respiration and citrate synthase enzyme; Quantify and qualify: mitochondrial number, endoplasmic reticulum structure, adipose cell size; Gene expression, quantify by microscopy and analyze the protein by western blot.
The study began with 20 women, however, there was withdrawal of 6, ending with 14 women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Training | Other | Other: Physical TrainingThere was concurrent physical training intervention: strength and aerobic exercises in the same session. Duration: 2 weeks of adaptation and learning to exercise, 8 weeks of physical training. Frequency: 3 times per week Duration: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study included women with obesity (BMI of 30 to 40 kg / m²), sedentary, with no associated comorbidity, convenience sample
Key exclusion criteria (1 listed)
- Women who have undergone bariatric surgery, menopause, cancer or any metabolic disease, smokers, alcoholics, who are in use of drugs that act directly on the metabolism and that have medical impediment to the practice of physical exercise.
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 |
|---|---|---|
| Physical TrainingIntervention with concurrent physical training: strength and aerobic exercises in the same session. Duration: 2 weeks of adaptation to physical exercise, 8 weeks of training. Frequency: 3 times a week. Time: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate. | Other | Physical Training |
Primary outcome
Changes Body weight
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Body weight was measured by digital balance before and after the intervention
Changes Body composition
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
The change in body composition through deuterium oxide was evaluated.
Changes White adipose tissue biopsy
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
A subcutaneous tissue sample was collected for analysis of: mitochondrial respiration, citrate synthase enzyme, gene expression (UCP1, 2 and 3).
Changes Indirect calorimetry
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (Lipids and carbohydrates).
Changes in fatty acids
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Collected in lithium heparin tubes, they were centrifuged.
Changes oxidative stress
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Collected in lithium heparin tubes, they were centrifuged.
Changes inflammatory cytokines
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Collected in lithium heparin tubes, they were centrifuged.
Changes in total cholesterol
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Collected in lithium heparin tubes, they were centrifuged.
Changes Physical Performance
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Based on the Shuttle Walking Test adaptation.
Changes in Determination of Lactate
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Blood samples were collected by manual puncture of the earlobe in previously calibrated and heparinized capillary tubes, stored in eppendorf with sodium fluoride. Analyzed by electrochemical lactate analyser.
Changes Food intake
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Food registry of 3 days, the quantification of the daily intake of nutrients will still be made using software.
Changes Nitrogen Balance
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Through the collection of urine of 24 hours the dosage of urinary nitrogen will be made by the chemiluminescence method for determination of protein nitrogen.
Changes Telomere length
Time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
peripheral blood in ethylenediaminetetraacetic acid tubes and genomic DNA was automatically extracted from Peripheral Blood Mononuclear Cell. The relative quantification of Telomere length was determined using the telomere to single copy gene ratio by Quantitative Polymerase Chain Reaction (qPCR).
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 30 Apr 2019.
- BackgroundBROWN, L.E.; WEIR, J.P.; ASEP procedures recommendation i: accurate assessment of muscular strength and power, Journal of Exercise Physiology, v. 4, n. 3, p. 1-21, 2001.
- Background: PubMed 17991697Burgomaster KA, Howarth KR, Phillips SM, Rakobowchuk M, Macdonald MJ, McGee SL, Gibala MJ. Similar metabolic adaptations during exercise after low volume sprint interval and traditional endurance training in humans. J Physiol. 2008 Jan 1;586(1):151-60. doi: 10.1113/jphysiol.2007.142109. Epub 2007 Nov 8.
- Background: PubMed 2440339Chomczynski P, Sacchi N. Single-step method of RNA isolation by acid guanidinium thiocyanate-phenol-chloroform extraction. Anal Biochem. 1987 Apr;162(1):156-9. doi: 10.1006/abio.1987.9999.
- BackgroundColégio Americano de Medicina Esportiva, CAME. Guia para Teste de Esforço e Prescrição de Exercício. 3º Edição, Medsi, Rio de janeiro, RJ, p.25, 1987.
- Background: PubMed 27867205Crump C, Sundquist J, Winkleby MA, Sundquist K. Interactive effects of obesity and physical fitness on risk of ischemic heart disease. Int J Obes (Lond). 2017 Feb;41(2):255-261. doi: 10.1038/ijo.2016.209. Epub 2016 Nov 21.
- Background: PubMed 20150287Curtis JM, Grimsrud PA, Wright WS, Xu X, Foncea RE, Graham DW, Brestoff JR, Wiczer BM, Ilkayeva O, Cianflone K, Muoio DE, Arriaga EA, Bernlohr DA. Downregulation of adipose glutathione S-transferase A4 leads to increased protein carbonylation, oxidative stress, and mitochondrial dysfunction. Diabetes. 2010 May;59(5):1132-42. doi: 10.2337/db09-1105. Epub 2010 Feb 11.
- Background: PubMed 18417645Daussin FN, Zoll J, Dufour SP, Ponsot E, Lonsdorfer-Wolf E, Doutreleau S, Mettauer B, Piquard F, Geny B, Richard R. Effect of interval versus continuous training on cardiorespiratory and mitochondrial functions: relationship to aerobic performance improvements in sedentary subjects. Am J Physiol Regul Integr Comp Physiol. 2008 Jul;295(1):R264-72. doi: 10.1152/ajpregu.00875.2007. Epub 2008 Apr 16.
- BackgroundEIGENTLER, A.; DRAXL, A.; et al. Laboratory Protocol: Citrate synthase a mitochondrial marker enzyme. Mitochondrial Physiology Network, v. 17.04, n. 3, p. 1-11, 2015.
- Background: PubMed 26471784Fernstrom M, Bakkman L, Loogna P, Rooyackers O, Svensson M, Jakobsson T, Brandt L, Lagerros YT. Improved Muscle Mitochondrial Capacity Following Gastric Bypass Surgery in Obese Subjects. Obes Surg. 2016 Jul;26(7):1391-7. doi: 10.1007/s11695-015-1932-z.
- Background: PubMed 27385544Ferreira FC, Bertucci DR, Barbosa MR, Nunes JE, Botero JP, Rodrigues MF, Shiguemoto GE, Santoro V, Verzola AC, Nonaka RO, Verzola RM, Baldissera V, Perez SE. Circuit resistance training in women with normal weight obesity syndrome: body composition, cardiometabolic and echocardiographic parameters, and cardiovascular and skeletal muscle fitness. J Sports Med Phys Fitness. 2017 Jul-Aug;57(7-8):1033-1044. doi: 10.23736/S0022-4707.16.06391-X. Epub 2016 Jul 6.
- BackgroundFETT, C.A.; FETT, W.C.R.; MARCHINI, J.S. Fitness Level of Overweight/Obese Women After 08 Weeks of Aerobic or Mixed Metabolism Exercises. Revista Brasileira de Cineantropometria & Desempenho Humano, v. 11, p. 261-266, 2009.
- Background: PubMed 9662690Foster C. Monitoring training in athletes with reference to overtraining syndrome. Med Sci Sports Exerc. 1998 Jul;30(7):1164-8. doi: 10.1097/00005768-199807000-00023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Training in people with Metabolism Disorder and Mitochondrial Alteration, 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 1 inclusion and 1 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 30 Apr 2019. 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. 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?
Changes Body weight (time frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03119350, which also lists 28 linked publications.
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 30 Apr 2019.