ObesityNCT06579508
Effects of High-intensity Exercise With Hypoxia and Taurine Supplementation on Metabolic and Mitochondrial Parameters
A study testing Cycle ergometer in people with Obesity, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The prevalence of obesity in Brazil is one of the highest in Latin America. As an inflammatory disease, obesity needs to be treated, and one of the best interventions is exercise. This research aims to learn more about the effects of combining high-intensity training, recovery hypoxia, and taurine supplementation. 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?
- Cycle ergometer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
2 sites in 1 country.
Brazil2 sites
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
Ribeirão Preto, São Paulo, 14049-900
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Effects of High-intensity Intermittent Exercise With Recovery Hypoxia and Taurine Supplementation in Women With Obesity on Metabolic and Mitochondrial Parameters
The prevalence of obesity in Brazil is one of the highest in Latin America. As an inflammatory disease, obesity needs to be treated, and one of the best interventions is exercise. This research aims to learn more about the effects of combining high-intensity training, recovery hypoxia, and taurine supplementation. To better understand these effects, the researchers will compare hypoxia and normoxia, as well as taurine and placebo, with all participants training in the same way. The researchers will also investigate mitochondrial respiration and food consumption to connect certain aspects of obesity with overall health.
Read the detailed description
Obesity is characterized by a chronic inflammatory state, often linked with elevated oxidative stress and mitochondrial dysfunction. While physical exercise can trigger inflammatory responses due to muscle damage, it also promotes significant bodily adaptations, particularly in body composition, physical fitness, and skeletal muscle tissue, including enhanced mitochondrial dynamics. Moderate hypoxia, when combined with exercise, further amplifies these benefits by increasing the expression of genes related to mitochondrial biogenesis, GLUT1 expression, and angiogenesis. Previous findings suggest that high-intensity physical activity not only improves cardiorespiratory capacity and alters body composition but also significantly elevates inflammation. Consequently, taurine, a supplement known for its anti-inflammatory properties and ability to reduce oxidative stress, should be considered to mitigate these issues and optimize the benefits of exercise and hypoxia. Based on these premises, it is hypothesized that the combination of taurine supplementation with physical training under recovery hypoxia may reduce the significant rise in pro-inflammatory cytokines, thereby enhancing the potential benefits of exercise and moderate hypoxia.
- Conditions
- Obesity
- Being tested
- Cycle ergometer
- Keywords
- Mitochondrial disfunction, Oxidative stress, Inter-effort Hypoxia, Physical Exercise, Obesity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ergometerOther
Also called Bike
The initial part will last 5 minutes at low intensity, corresponding to "easy" by the RPE.
The main part will be performed at the intensity of training zone 3 (100-110% of the Lan), lasting 5 minutes with a rest of 2.5 minutes between exercises. The intensity will be controlled by HR and RPE.
The final part will last 3 minutes at low intensity, corresponding to "easy" by the RPE.
The load progression occurred during the first four weeks, starting with 3 sets and adding 1 set per week.
The intensity of each effort is 100-110%HRAnTh.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention, only the evaluations will be done. |
| Normoxia - Placebo | Placebo comparator | High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%). Receives: Other: Cycle ergometer |
| Normoxia - Taurina | Placebo comparator | High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%). Receives: Other: Cycle ergometer |
| Hypoxia - Placebo | Placebo comparator | High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%). Receives: Other: Cycle ergometer |
| Hypoxia - Taurina | Experimental | High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%). Receives: Other: Cycle ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry - Height
Dual energy x-ray absorptiometry (DEXA) will be use for:
Height measured in meters.
Measured: 12 weeks
Anthropometry - Weight
Dual energy x-ray absorptiometry (DEXA) will be use for:
Changes in body weight in kilograms (kg).
Measured: 12 weeks
Anthropometry - BMI
Dual energy x-ray absorptiometry (DEXA) will be use for:
Changes in body mass index (BMI = weight measured(kg) / (height (m)²).
Measured: 12 weeks
Body composition - Free-fat mass
Dual energy x-ray absorptiometry (DEXA) will be use for:
Changes in body composition for fat-free mass (grams and %).
Measured: 12 weeks
Body composition - Fat mass
Dual energy x-ray absorptiometry (DEXA) will be use for:
Changes in body composition for fat mass (grams and %).
Measured: 12 weeks
Body composition - Bone
Dual energy x-ray absorptiometry (DEXA) will be use for:
Changes in body composition for bone mineral content (g.cm²).
Measured: 12 weeks
Lipid profile - Cholesterol
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:
Changes in total cholesterol (mg/dL).
Measured: 12 weeks
Lipid profile - Triglycerides
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:
Changes in triglycerides (mg/dL).
Measured: 12 weeks
Lipid profile - HDL/LDL
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:
Changes in HDL-cholesterol and LDL-cholesterol (mg/dL).
Measured: 12 weeks
Lipid profile - Glucose
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:
Changes in blood glucose (mg/dL).
Measured: 12 weeks
Inflammatory profile - pro inflammatory
Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-6, TNF-α (pg/mL).
Measured: 12 weeks
Inflammatory profile - anti inflammatory
Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Ant- inflammatory citokines: IL-10 (pg/mL), Adiponectin (ng/mL).
Measured: 12 weeks
Aerobic performance - HRAnTh
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:
Anaerobic threshold (AT) using heart rate (HR).
Measured: 12 weeks
Aerobic performance - IAnTh
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:
Anaerobic threshold (AT) using intensity in Watts (W).
Measured: 12 weeks
Aerobic performance - RPEAnTh
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:
Anaerobic threshold (AT) using Rate of Perceived Effort (RPE).
Measured: 12 weeks
Aerobic performance - LacAnTh
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:
Anaerobic threshold (AT) using lactate concentration [lac-].
Measured: 12 weeks
Aerobic performance - VO2
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:
VO2peak in ml.kg-1.min-1.
Measured: 12 weeks
Food Intake
A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last 12 weeks. Will be evaluated with Dietwin® software (São Paulo, Brazil):
The macronutrients, micronutrients and fiber in quilocalories and percentage (%)
Measured: 12 weeks
Food quality
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: 12 weeks
Taurine rates
The participants will supplement 3g of taurina or placebo during 12 weeks. The rate of plasmatic taurine (mmol) will be evaluated during pre and post intervention.
Measured: 12 weeks
Muscle biopsy - RNA
After biopsy the tissue will be treated for:
qPCR analysis.
Measured: 12 weeks
Muscle biopsy - Protein
After biopsy the tissue will be treated for:
Western blotting analysis.
Measured: 12 weeks
Muscle biopsy - Mitochondria
After biopsy the tissue will be treated for:
High-resolution respirometry of muscle fibers analysis.
Measured: 12 weeks
Secondary outcomes (4)
Training measures - RPE
The Borg scale will be use to quantify the:
Rate of Perceived Effort (RPE) - will be noted after each effort during all the training program.
Measured: 12 weeks
Training measures - TRIMP
The internal load will be calculated using TRIMP:
Calculated multipling the RPE for the time in effort (TRIMP = RPE * time in effort), for each participant and training session.
Measured: 12 weeks
Training measures - SP02
The Oxygen saturation (SpO2) will be measure in percent (%), using a pulse oximeter.
SpO2 (%) will be noted after the end of the effort, the lowest point during the rest and in the end of the rest.
Measured: 12 weeks
Training measures - HR
The heart rate (HR) will be measure in beats per minute (BPM) with Polar clock.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Mar 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- 50 participants (estimated)
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 Viliod, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579508
- Sponsor's protocol ID
- Hypoxia_Taurine
- Status last verified
- May 2025
- First submitted
- 20 Aug 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Intermittent Exercise With Recovery Hypoxia and Taurine Supplementation in Women With Obesity on Metabolic and Mitochondrial Parameters
- ClinicalTrials.gov ID
- NCT06579508
- Acronym / sponsor ID
- Hypoxia_Taurine
- Conditions
- Obesity
- Keywords
- Mitochondrial disfunction, Oxidative stress, Inter-effort Hypoxia, Physical Exercise, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (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 prevalence of obesity in Brazil is one of the highest in Latin America. As an inflammatory disease, obesity needs to be treated, and one of the best interventions is exercise. This research aims to learn more about the effects of combining high-intensity training, recovery hypoxia, and taurine supplementation. To better understand these effects, the researchers will compare hypoxia and normoxia, as well as taurine and placebo, with all participants training in the same way. The researchers will also investigate mitochondrial respiration and food consumption to connect certain aspects of obesity with overall health.
Detailed description
Obesity is characterized by a chronic inflammatory state, often linked with elevated oxidative stress and mitochondrial dysfunction. While physical exercise can trigger inflammatory responses due to muscle damage, it also promotes significant bodily adaptations, particularly in body composition, physical fitness, and skeletal muscle tissue, including enhanced mitochondrial dynamics. Moderate hypoxia, when combined with exercise, further amplifies these benefits by increasing the expression of genes related to mitochondrial biogenesis, GLUT1 expression, and angiogenesis. Previous findings suggest that high-intensity physical activity not only improves cardiorespiratory capacity and alters body composition but also significantly elevates inflammation. Consequently, taurine, a supplement known for its anti-inflammatory properties and ability to reduce oxidative stress, should be considered to mitigate these issues and optimize the benefits of exercise and hypoxia. Based on these premises, it is hypothesized that the combination of taurine supplementation with physical training under recovery hypoxia may reduce the significant rise in pro-inflammatory cytokines, thereby enhancing the potential benefits of exercise and moderate hypoxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention, only the evaluations will be done. |
| Normoxia - Placebo | Placebo comparator | Other: Cycle ergometerHigh-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%). |
| Normoxia - Taurina | Placebo comparator | Other: Cycle ergometerHigh-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%). |
| Hypoxia - Placebo | Placebo comparator | Other: Cycle ergometerHigh-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%). |
| Hypoxia - Taurina | Experimental | Other: Cycle ergometerHigh-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%). |
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 |
|---|---|---|
| Cycle ergometerAlso: BikeThe initial part will last 5 minutes at low intensity, corresponding to "easy" by the RPE. The main part will be performed at the intensity of training zone 3 (100-110% of the Lan), lasting 5 minutes with a rest of 2.5 minutes between exercises. The intensity will be controlled by HR and RPE. The final part will last 3 minutes at low intensity, corresponding to "easy" by the RPE. The load progression occurred during the first four weeks, starting with 3 sets and adding 1 set per week. The intensity of each effort is 100-110%HRAnTh. | Other | Hypoxia - Placebo, Hypoxia - Taurina, Normoxia - Placebo, Normoxia - Taurina |
Primary outcome
Anthropometry - Height
Time frame: 12 weeks
Dual energy x-ray absorptiometry (DEXA) will be use for: Height measured in meters.
Anthropometry - Weight
Time frame: 12 weeks
Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body weight in kilograms (kg).
Anthropometry - BMI
Time frame: 12 weeks
Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body mass index (BMI = weight measured(kg) / (height (m)²).
Body composition - Free-fat mass
Time frame: 12 weeks
Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat-free mass (grams and %).
Body composition - Fat mass
Time frame: 12 weeks
Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat mass (grams and %).
Body composition - Bone
Time frame: 12 weeks
Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for bone mineral content (g.cm²).
Lipid profile - Cholesterol
Time frame: 12 weeks
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in total cholesterol (mg/dL).
Lipid profile - Triglycerides
Time frame: 12 weeks
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in triglycerides (mg/dL).
Lipid profile - HDL/LDL
Time frame: 12 weeks
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in HDL-cholesterol and LDL-cholesterol (mg/dL).
Lipid profile - Glucose
Time frame: 12 weeks
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in blood glucose (mg/dL).
Inflammatory profile - pro inflammatory
Time frame: 12 weeks
Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-6, TNF-α (pg/mL).
Inflammatory profile - anti inflammatory
Time frame: 12 weeks
Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Ant- inflammatory citokines: IL-10 (pg/mL), Adiponectin (ng/mL).
Aerobic performance - HRAnTh
Time frame: 12 weeks
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using heart rate (HR).
Aerobic performance - IAnTh
Time frame: 12 weeks
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using intensity in Watts (W).
Aerobic performance - RPEAnTh
Time frame: 12 weeks
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using Rate of Perceived Effort (RPE).
Aerobic performance - LacAnTh
Time frame: 12 weeks
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using lactate concentration [lac-].
Aerobic performance - VO2
Time frame: 12 weeks
Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: VO2peak in ml.kg-1.min-1.
Food Intake
Time frame: 12 weeks
A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last 12 weeks. Will be evaluated with Dietwin® software (São Paulo, Brazil): The macronutrients, micronutrients and fiber in quilocalories and percentage (%)
Food quality
Time frame: 12 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.
Taurine rates
Time frame: 12 weeks
The participants will supplement 3g of taurina or placebo during 12 weeks. The rate of plasmatic taurine (mmol) will be evaluated during pre and post intervention.
Muscle biopsy - RNA
Time frame: 12 weeks
After biopsy the tissue will be treated for: qPCR analysis.
Muscle biopsy - Protein
Time frame: 12 weeks
After biopsy the tissue will be treated for: Western blotting analysis.
Muscle biopsy - Mitochondria
Time frame: 12 weeks
After biopsy the tissue will be treated for: High-resolution respirometry of muscle fibers analysis.
4 secondary outcomes
Training measures - RPE
Time frame: 12 weeks
Training measures - TRIMP
Time frame: 12 weeks
Training measures - SP02
Time frame: 12 weeks
Training measures - HR
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- 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 Viliod principal investigator
USP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle ergometer in people with Obesity, run by University of Sao Paulo at 2 sites 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Anthropometry - Height (time frame: 12 weeks). The study lists 23 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 11 May 2026.