Obesity (BMI>30)non applicableNCT07711899
Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise
A study testing Physical Training of 16 weeks in people with Obesity (BMI>30) and Metabolically Healthy Obesity, run by University of Sao Paulo.
Trial summary
Population aging has been accompanied by a rise in obesity and other chronic diseases, increasing cardiovascular risk particularly among women, who exhibit a higher prevalence in older age groups compared to men. Aging and obesity share pathophysiological mechanisms, such as chronic inflammation and oxidative stress. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity (BMI>30), Metabolically Healthy Obesity, Metabolically Unhealty Obese
- What is being tested?
- Physical Training of 16 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Mar 2030
- 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 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 60 to 75 years.
- Residents of the city or region of Ribeirão Preto, São Paulo, Brazil.
- Physically inactive for at least 3 months.
- Body mass index (BMI) ≥ 30 kg/m² (PAHO, 2002).
- Body fat percentage ≥ 35%, according to obesity diagnostic criteria (Batsis et al., 2016; Rubino et al., 2025).
- Classified into one of two obesity phenotypes based on Zembic et al. (2021):
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- Metabolically Healthy Obesity (MHO/OMS): all of the following criteria must be met:
- Systolic blood pressure (SBP) < 130 mmHg;
- Waist-to-hip ratio < 0.95;
- Fasting blood glucose < 126 mg/dL.
- Metabolically Unhealthy Obesity (MUO/OMNS): meets two or fewer of the above criteria.
Who cannot join
- Clinical conditions
- Contraindication to physical exercise.
- Current or previous diagnosis of:
- Neoplasms;
- Autoimmune diseases;
- Hepatic diseases;
Show all 21Show fewer
- Coronary diseases;
- Renal diseases;
- Neurodegenerative diseases;
- Infectious diseases.
- Previous or ongoing treatments
- Use of medication for thyroid disorders.
- Participation in exercise training programs, nutritional counseling, or weight loss treatment within the 3 months preceding the intervention.
- Lifestyle habits
- Current smoking.
- Alcohol consumption.
- For MHO Group:
- Medication use
- Hypoglycemic agents
- Insulin (Bell, Kivimäki, \& Hamer, 2014).
- Protocol adherence *Attendance at less than 80% of the training sessions (De Carvalho et al., 2021).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Plasma Taurine Concentrations in Older Women With Obesity: The Influence of Metabolic Phenotype and Combined Exercise Training
Population aging has been accompanied by a rise in obesity and other chronic diseases, increasing cardiovascular risk particularly among women, who exhibit a higher prevalence in older age groups compared to men. Aging and obesity share pathophysiological mechanisms, such as chronic inflammation and oxidative stress. However, distinct obesity phenotypes exist, such as metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO). Consequently, therapeutic interventions involving nutritional strategies and physical training are highly relevant, especially for older women. Taurine, a sulfur-containing amino acid, plays a role in modulating oxidative stress, inflammation, osmoregulation, and mitochondrial function. Rationale: Plasma taurine concentrations are lower in women with obesity compared to healthy individuals. However, studies investigating these concentrations across different phenotypes-particularly in older women, a group susceptible to functional and metabolic changes-remain limited. Understanding these variations could clarify taurine's role in the pathophysiology of obesity and aging and inform personalized therapeutic strategies. Combined physical training stands out as an effective strategy for modulating inflammatory, oxidative, and metabolic pathways, in addition to improving psychosocial aspects. Given that taurine levels can be influenced by these pathways, investigating the taurine response to physical training across different metabolic phenotypes may contribute to developing low-cost interventions aimed at improving the quality of life for older women with obesity.
Read the detailed description
This study aims to investigate differences in plasma taurine concentrations between older women with MHO and MUO, and to evaluate the response of taurine-as well as metabolic, inflammatory, oxidative, and cellular markers-to a 16-week combined physical training intervention. The study will involve 36 older women with obesity, classified as having either MHO or MUO. In Stage 1, nutritional and anthropometric assessments will be conducted, along with the collection of biological samples for biochemical and molecular analyses. In Stage 2, participants will undergo a combined physical exercise intervention for 16 weeks; nutritional, anthropometric, physical performance, and functional assessments will be performed, as well as the collection of biological samples for pre- and post-intervention biochemical and molecular analyses. Stage 3 will consist of integrated data analysis to identify variables predicting plasma taurine concentrations at baseline and post-intervention. Data analysis method: Data will be analyzed using Student's t-tests or Mann-Whitney tests (Stage 1), ANOVA or Kruskal-Wallis tests (Stage 2), Pearson or Spearman correlations (Stages 1 and 2), and linear regression models (Stage 3), using SPSS software (α=5%). Expected results: It is expected that older women with OMS will exhibit higher baseline taurine concentrations and that combined physical training will increase these concentrations in both groups-with a more pronounced effect in the OMS phenotype-in addition to promoting cardiometabolic, functional, inflammatory, oxidative, and psychosocial benefits.
- Being tested
- Physical Training of 16 weeks
- Keywords
- Taurine, Metabolically unhealthy obesity., Metabolically healthy obesity., Physical training, Aging
- Medical subject headings
- Obesity, Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Training of 16 weeksBehavioural
Combined physical Training during 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Metabolically Healthy Obesity (MHO) | Other | Women with metabolically healthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype. Receives: Behavioral: Physical Training of 16 weeks |
| Metabolically Unhealthy Obesity (MUO) | Other | Women with metabolically unhealthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype. Receives: Behavioral: Physical Training of 16 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma taurine concentrations (µmol/L).
It will be analyzed by high-performance liquid chromatography.
Measured: 16 weeks
Secondary outcomes (34)
Systolic and diastolic blood pressure (mmHg)
Using sphygmomanometer
Measured: 16 weeks
Waist and hip circumferences (cm)
non-stretch anthropometric tape
Measured: 16 weeks
Appendicular lean soft tissue (kg).
Using Dual-energy X-ray Absorptiometry (DXA), often referred to as iDXA, is a low-dose X-ray technology that measures bone mineral density (BMD) and body composition
Measured: 16 Weeks
Total and regional body fat percentage (%)
Dual-energy X-ray Absorptiometry
Measured: 16 weeks
Visceral fat (kg)
Dual-energy X-ray Absorptiometry
Measured: 16 weeks
Body mass (kg)
Dual-energy X-ray Absorptiometry
Measured: 16 weeks
Body mass index, BMI (kg/m²).
Using body mass and height measurements
Measured: 16 weeks
Inflammatory and antiinflamatory profile
Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-1β, MCP-1,TNF-α, IL-6, IL-13 (pg/mL), leptina e PCR-us (mg/dL), IL-10 (pg/mL) e adiponectina (mg/dL).
Measured: 16 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 16 weeks. Will be evaluated with Dietwin® software (São Paulo, Brazil):
The macronutrients, micronutrients and fiber in quilocalories and percentage (%)
Measured: 16 weeks
Aerobic performance - VO2
Physical tests performed pre 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: 16 weeks
Aerobic performance - LacAnTh
Physical tests performed pre 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: 16 weeks
Aerobic performance - IAnTh
Physical tests performed pre 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: 16 weeks
Aerobic performance - HRAnTh
Physical tests performed pre 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: 16 weeks
Food intake - frequency
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
Measured: 16 weeks
Strength test - leg press
Strength test - leg press - maximum repetitions pre and post intervention
Measured: 16 weeks
Strength test - bench press
Strength test using bench press, pre and post intervention
Measured: 16 weeks
Funtional capacity: chair sit-to-stand
Funtional capacity evaluation pre and post intervention
Measured: 16 weeks
handgrip strength
handgrip strength using manual dinamometer
Measured: 16 weeks
funtional capacity: elbow flexion and extension
funtional capacity: elbow flexion and extension using a dumpbell
Measured: 16 weeks
Funtional capacity: 6-minute walk test
6-minute walk test using an 30-meter course with markings every 3 meters.
Measured: 16 weeks
Glycemic profile
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: 16 weeks
Lipid profile - Total 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: 16 weeks
Lipid profile: HDL-cholesterol and LDL-cholesterol (mg/dL).
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: 16 weeks
Lipid profile: triglycerides (mg/dL).
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: 16 weeks
Glycemic profile - C-peptide
C-peptide pre and post intervention using Chemiluminescence (CLIA - Chemiluminescent Immunoassay)
Measured: 16 weeks
Expression of inflammatory and anti-inflammatory genes in peripheral blood mononuclear cells (PBMCs)
Using RT-qPCR pre and post-intervention.
Measured: 16 weeks
Expression of genes related to telomere length: TRF1, TRF2, RAP1, TPP1, POT1, TIN2, and hTERT.
Using RT-qPCR pre and post intervention
Measured: 16 weeks
Micronutrients (mg/dL)
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
Measured: 16 weeks
Antioxidant enzymes - Superoxide dismutase
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
Measured: 16 weeks
Antioxidants enzymes - Catalase (CAT)
Catalase Assay Kit Pre and post intervention (U/mg)
Measured: 16 weeks
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Glutathione Peroxidase Assay Kit Pre and post intervention
Measured: 16 weeks
Oxidative stress markers - Malondialdehyde (nmol/mL).
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
Measured: 16 weeks
Relative telomere length
The assay will be based on quantifying the ratio between the amplification of telomeric sequences (T) and a single-copy gene (S), enabling the estimation of relative telomere length in the biological samples.
Measured: 16 weeks
Nitrogen balance
Urinary nitrogen excretion (g) will be determined using the Labtest Diagnóstica kit (UREA CE), estimating urinary nitrogen excretion based on urea levels. Daily protein intake will also be used, pre and post intervention
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A study comprising three sequential and interdependent stages will be conducted; the first stage will employ a cross-sectional, descriptive-analytical design and adhere to the "Strengthening the Reporting of Observational Studies in Epidemiology" (STROBE) recommendations. The sample will consist of 36 elderly women with obesity, allocated into two groups based on the OMS and OMNS classifications (18 elderly women per group). The second stage will be a 16-week clinical trial following the CONSORT checklist (HOPEWELL et al., 2025). In this stage, both groups (OMS and OMNS) will undergo a physical training intervention over the course of 16 weeks. Stage 3 will consist of an integrated analysis of data obtained in stages 1 and 2 to examine factors explaining potential variability in plasma taurine concentrations. No new data collection procedures will be performed during this stage, as all necessary data will be derived from previously conducted assessments.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711899
- Sponsor's protocol ID
- Taurine_Obesity_Phenotypes
- Other IDs
- 2025/17801-3, 2025
- Acronym
- non applicable
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Taurine Concentrations in Older Women With Obesity: The Influence of Metabolic Phenotype and Combined Exercise Training
- ClinicalTrials.gov ID
- NCT07711899
- Acronym / sponsor ID
- non applicable / Taurine_Obesity_Phenotypes
- Keywords
- Taurine, Metabolically unhealthy obesity., Metabolically healthy obesity., Physical training, Aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 17 Jul 2026 (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.
Population aging has been accompanied by a rise in obesity and other chronic diseases, increasing cardiovascular risk particularly among women, who exhibit a higher prevalence in older age groups compared to men. Aging and obesity share pathophysiological mechanisms, such as chronic inflammation and oxidative stress. However, distinct obesity phenotypes exist, such as metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO). Consequently, therapeutic interventions involving nutritional strategies and physical training are highly relevant, especially for older women. Taurine, a sulfur-containing amino acid, plays a role in modulating oxidative stress, inflammation, osmoregulation, and mitochondrial function. Rationale: Plasma taurine concentrations are lower in women with obesity compared to healthy individuals. However, studies investigating these concentrations across different phenotypes-particularly in older women, a group susceptible to functional and metabolic changes-remain limited. Understanding these variations could clarify taurine's role in the pathophysiology of obesity and aging and inform personalized therapeutic strategies. Combined physical training stands out as an effective strategy for modulating inflammatory, oxidative, and metabolic pathways, in addition to improving psychosocial aspects. Given that taurine levels can be influenced by these pathways, investigating the taurine response to physical training across different metabolic phenotypes may contribute to developing low-cost interventions aimed at improving the quality of life for older women with obesity.
Detailed description
This study aims to investigate differences in plasma taurine concentrations between older women with MHO and MUO, and to evaluate the response of taurine-as well as metabolic, inflammatory, oxidative, and cellular markers-to a 16-week combined physical training intervention. The study will involve 36 older women with obesity, classified as having either MHO or MUO. In Stage 1, nutritional and anthropometric assessments will be conducted, along with the collection of biological samples for biochemical and molecular analyses. In Stage 2, participants will undergo a combined physical exercise intervention for 16 weeks; nutritional, anthropometric, physical performance, and functional assessments will be performed, as well as the collection of biological samples for pre- and post-intervention biochemical and molecular analyses. Stage 3 will consist of integrated data analysis to identify variables predicting plasma taurine concentrations at baseline and post-intervention. Data analysis method: Data will be analyzed using Student's t-tests or Mann-Whitney tests (Stage 1), ANOVA or Kruskal-Wallis tests (Stage 2), Pearson or Spearman correlations (Stages 1 and 2), and linear regression models (Stage 3), using SPSS software (α=5%). Expected results: It is expected that older women with OMS will exhibit higher baseline taurine concentrations and that combined physical training will increase these concentrations in both groups-with a more pronounced effect in the OMS phenotype-in addition to promoting cardiometabolic, functional, inflammatory, oxidative, and psychosocial benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A study comprising three sequential and interdependent stages will be conducted; the first stage will employ a cross-sectional, descriptive-analytical design and adhere to the "Strengthening the Reporting of Observational Studies in Epidemiology" (STROBE) recommendations. The sample will consist of 36 elderly women with obesity, allocated into two groups based on the OMS and OMNS classifications (18 elderly women per group). The second stage will be a 16-week clinical trial following the CONSORT checklist (HOPEWELL et al., 2025). In this stage, both groups (OMS and OMNS) will undergo a physical training intervention over the course of 16 weeks. Stage 3 will consist of an integrated analysis of data obtained in stages 1 and 2 to examine factors explaining potential variability in plasma taurine concentrations. No new data collection procedures will be performed during this stage, as all necessary data will be derived from previously conducted assessments.
| Arm | Type | Receives |
|---|---|---|
| Metabolically Healthy Obesity (MHO) | Other | Behavioral: Physical Training of 16 weeksWomen with metabolically healthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype. |
| Metabolically Unhealthy Obesity (MUO) | Other | Behavioral: Physical Training of 16 weeksWomen with metabolically unhealthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women aged 60 to 75 years.
- Residents of the city or region of Ribeirão Preto, São Paulo, Brazil.
- Physically inactive for at least 3 months.
- Body mass index (BMI) ≥ 30 kg/m² (PAHO, 2002).
- Body fat percentage ≥ 35%, according to obesity diagnostic criteria (Batsis et al., 2016; Rubino et al., 2025).
Key exclusion criteria (21 listed)
- Clinical conditions
- Contraindication to physical exercise.
- Current or previous diagnosis of:
- Previous or ongoing treatments
- Use of medication for thyroid disorders.
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 Training of 16 weeksCombined physical Training during 16 weeks | Behavioural | Metabolically Healthy Obesity (MHO), Metabolically Unhealthy Obesity (MUO) |
Primary outcome
Plasma taurine concentrations (µmol/L).
Time frame: 16 weeks
It will be analyzed by high-performance liquid chromatography.
34 secondary outcomes
Systolic and diastolic blood pressure (mmHg)
Time frame: 16 weeks
Waist and hip circumferences (cm)
Time frame: 16 weeks
Appendicular lean soft tissue (kg).
Time frame: 16 Weeks
Total and regional body fat percentage (%)
Time frame: 16 weeks
Visceral fat (kg)
Time frame: 16 weeks
Body mass (kg)
Time frame: 16 weeks
Body mass index, BMI (kg/m²).
Time frame: 16 weeks
Inflammatory and antiinflamatory profile
Time frame: 16 weeks
Food Intake
Time frame: 16 weeks
Aerobic performance - VO2
Time frame: 16 weeks
Aerobic performance - LacAnTh
Time frame: 16 weeks
Aerobic performance - IAnTh
Time frame: 16 weeks
Aerobic performance - HRAnTh
Time frame: 16 weeks
Food intake - frequency
Time frame: 16 weeks
Strength test - leg press
Time frame: 16 weeks
Strength test - bench press
Time frame: 16 weeks
Funtional capacity: chair sit-to-stand
Time frame: 16 weeks
handgrip strength
Time frame: 16 weeks
funtional capacity: elbow flexion and extension
Time frame: 16 weeks
Funtional capacity: 6-minute walk test
Time frame: 16 weeks
Glycemic profile
Time frame: 16 weeks
Lipid profile - Total cholesterol
Time frame: 16 weeks
Lipid profile: HDL-cholesterol and LDL-cholesterol (mg/dL).
Time frame: 16 weeks
Lipid profile: triglycerides (mg/dL).
Time frame: 16 weeks
Glycemic profile - C-peptide
Time frame: 16 weeks
Expression of inflammatory and anti-inflammatory genes in peripheral blood mononuclear cells (PBMCs)
Time frame: 16 weeks
Expression of genes related to telomere length: TRF1, TRF2, RAP1, TPP1, POT1, TIN2, and hTERT.
Time frame: 16 weeks
Micronutrients (mg/dL)
Time frame: 16 weeks
Antioxidant enzymes - Superoxide dismutase
Time frame: 16 weeks
Antioxidants enzymes - Catalase (CAT)
Time frame: 16 weeks
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Time frame: 16 weeks
Oxidative stress markers - Malondialdehyde (nmol/mL).
Time frame: 16 weeks
Relative telomere length
Time frame: 16 weeks
Nitrogen balance
Time frame: 16 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 20 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Training of 16 weeks in people with Obesity (BMI>30) and Metabolically Healthy Obesity, run by University of Sao Paulo.
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 11 inclusion and 21 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: opening soon, as of the sponsor's last update on 20 Jul 2026. 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?
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?
Contact Ellen Cristini de Freitas, Dr (+551633150345, ellenfreitas@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma taurine concentrations (µmol/L). (time frame: 16 weeks). 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 20 Jul 2026.