ObesitySES-EXNCT07370363
Exercise Effects on Cardiometabolic Health and Sestrin-2 in Hypertensive Obese Women
A study testing Moderate-Intensity Continuous Exercise and Brisk Interval Exercise in people with Obesity and Hypertension, run by Havva Talay Çalış at 1 site in Turkey (Türkiye).
Trial summary
Obesity is a chronic and complex disease characterized by excessive fat accumulation that adversely affects health and quality of life. It is commonly accompanied by low-grade chronic systemic inflammation, which contributes to the development of insulin resistance, type 2 diabetes, dyslipidemia, hypertension, and… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Moderate-Intensity Continuous Exercise and Brisk Interval Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Aug 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged between 30 and 65 years
- Body mass index between 30.0 and <40.0 kg/m² (Class I and Class II obesity)
- Diagnosis of hypertension according to the 2018 European Society of Hypertension/European Society of Cardiology (ESH/ESC) guidelines
- Sedentary lifestyle, defined as total weekly exercise duration of less than 60 minutes
- Medically eligible for exercise participation, with approval from a Physical Medicine and Rehabilitation specialist and an Internal Medicine specialist
- Willingness to participate in the study and provision of written informed consent
Who cannot join
- Neuromuscular disorders, uncontrolled psychiatric diseases, or cognitive impairment limiting exercise participation
- Congestive heart failure, unstable angina, or acute cardiac conditions including acute myocardial infarction, acute endocarditis, myocarditis, or pericarditis
- Presence of uncontrolled systemic diseases, including:
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Chronic liver failure
Show all 16Show fewer
- Chronic kidney disease or patients receiving dialysis
- Chronic obstructive pulmonary disease or asthma
- History or presence of malignancy
- Acute infection at the time of enrollment
- Acute peripheral vascular disease
- Symptomatic severe aortic stenosis
- Acute pulmonary embolism or pulmonary infarction
- Use of systemic corticosteroids or immunosuppressive medications
- Inability to comply with the study protocol or lack of cooperation
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kayseri City Hospital
Kayseri, Kayseri
Rukiye Akay, MD, 05392333789, rukiye.akay@sbu.edu.tr
About this study
Official title: Effects of Moderate-Intensity Continuous Exercise Versus Brisk Interval Exercise on Cardiometabolic Parameters and Sestrin-2 Levels in Hypertensive Obese Women: A Randomized Controlled Trial
Obesity is a chronic and complex disease characterized by excessive fat accumulation that adversely affects health and quality of life. It is commonly accompanied by low-grade chronic systemic inflammation, which contributes to the development of insulin resistance, type 2 diabetes, dyslipidemia, hypertension, and cardiovascular diseases. Hypertension is highly prevalent among individuals with obesity, and excess body weight is a major contributor to elevated blood pressure and related cardiometabolic risk.
Regular aerobic exercise is a cornerstone of non-pharmacological management for both obesity and hypertension and has been shown to reduce chronic inflammation by downregulating pro-inflammatory pathways and upregulating anti-inflammatory mechanisms. Sestrin-2, a stress-responsive protein encoded by the SESN2 gene, has been proposed as an important regulator of metabolic homeostasis and inflammation through activation of the AMPK pathway and inhibition of NF-κB signaling. However, evidence regarding the effects of different exercise modalities on circulating Sestrin-2 levels in hypertensive obese individuals remains limited.
This prospective, randomized controlled trial aims to compare the effects of two different aerobic exercise protocols on serum Sestrin-2 levels, inflammatory status, and cardiometabolic parameters in hypertensive obese women. Cardiopulmonary exercise testing will be used to comprehensively assess cardiorespiratory fitness and physiological responses to exercise. The results of this study are expected to contribute to a better understanding of exercise-induced anti-inflammatory mechanisms and to support the development of safe, effective, and applicable exercise prescriptions for hypertensive obese women.
Read the detailed description
Obesity is a chronic disease associated with excessive adipose tissue accumulation and a persistent low-grade inflammatory state, which contributes to the development of cardiometabolic disorders such as hypertension, insulin resistance, dyslipidemia, and cardiovascular disease. In women, the coexistence of obesity and hypertension substantially increases morbidity and negatively affects functional capacity and quality of life. Exercise training is a cornerstone of lifestyle-based management; however, the optimal characteristics of aerobic exercise prescription and its effects on emerging molecular biomarkers remain incompletely understood.
Sestrin-2 is a stress-inducible protein encoded by the SESN2 gene and has been implicated in metabolic regulation through activation of the AMP-activated protein kinase pathway and suppression of inflammatory signaling pathways, including nuclear factor kappa B. Experimental and clinical evidence suggests that Sestrin-2 may play a protective role against obesity-related inflammation and metabolic dysfunction. Nevertheless, data regarding the modulation of circulating Sestrin-2 levels in response to different aerobic exercise modalities in hypertensive obese women are limited.
This study is designed as a prospective, randomized controlled trial including hypertensive obese women who meet predefined eligibility criteria. Participants are randomly allocated to one of two supervised aerobic exercise intervention groups: moderate-intensity continuous exercise or brisk interval exercise. Both interventions are conducted for a predefined training period under standardized conditions.
Cardiopulmonary exercise testing is performed to assess cardiorespiratory fitness and physiological responses to exercise, including maximal oxygen consumption. Blood samples are collected to measure serum Sestrin-2 levels and cardiometabolic parameters. Additional assessments include lipid profile, indices of insulin resistance, anthropometric measurements, functional capacity evaluated by the six-minute walk test, and patient-reported questionnaire outcomes.
The primary outcome measures of the study are changes in serum Sestrin-2 levels and maximal oxygen consumption. Secondary outcome measures include changes in cardiometabolic risk factors, functional capacity, and anthropometric parameters. The findings of this study are expected to provide insight into exercise-induced anti-inflammatory mechanisms and to inform evidence-based aerobic exercise prescriptions for hypertensive obese women.
- Conditions
- Obesity, Hypertension
- Being tested
- Moderate-Intensity Continuous Exercise, Brisk Interval Exercise
- Keywords
- Hypertension, obesity, VO2max, Cardiopulmonary Exercise Testing, Sestrin-2, Aerobic Exercise
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Continuous ExerciseBehavioural
Supervised moderate-intensity continuous aerobic exercise performed at a prescribed intensity and frequency for the duration of the intervention period.
Brisk Interval ExerciseBehavioural
Supervised interval aerobic exercise consisting of alternating bouts of higher and moderate intensity performed throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Intensity Continuous Exercise | Experimental | Participants perform supervised moderate-intensity continuous aerobic exercise at a prescribed intensity and frequency. Receives: Behavioral: Moderate-Intensity Continuous Exercise |
| Brisk Interval Exercise | Experimental | Participants perform supervised interval aerobic exercise consisting of alternating bouts of higher and moderate intensity. Receives: Behavioral: Brisk Interval Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Sestrin-2 Level
Serum Sestrin-2 levels will be measured using enzyme-linked immunosorbent assay (ELISA).
Blood samples will be collected 48 hours before the start of the 8-week exercise program and 48 hours after completion of the intervention in order to avoid the acute effects of exercise.
The primary outcome is the change in Sestrin-2 levels from baseline to post-intervention.
Measured: Baseline and end of 8-week intervention
Maximal Oxygen Consumption (VO2max)
VO2max will be assessed using cardiopulmonary exercise testing (CPET) according to standardized protocols.
Measurements will be performed before the start of the exercise program and after completion of the 8-week intervention.
The change in VO2max from baseline to post-intervention will be analyzed.
Measured: Baseline and end of 8-week intervention
Secondary outcomes (9)
Lipid Profile
Fasting blood samples will be collected to assess lipid profile parameters, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride levels.
Standard laboratory methods will be used for biochemical analysis. Changes in lipid profile parameters from baseline to the end of the 8-week exercise intervention will be evaluated.
Measured: Baseline and end of 8-week intervention
Insulin Resistance
Insulin resistance will be assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Fasting plasma glucose and fasting insulin levels will be measured using standard laboratory methods, and HOMA-IR will be calculated accordingly.
The change in HOMA-IR from baseline to the end of the 8-week exercise intervention will be analyzed.
Measured: Baseline and end of 8-week intervention
Functional Capacity
Functional exercise capacity will be assessed using the 6-minute walk test (6MWT) according to established guidelines.
The total distance walked in six minutes will be recorded at baseline and after completion of the 8-week exercise intervention.
The change in 6-minute walk distance from baseline to post-intervention will be analyzed.
Measured: Baseline and end of 8-week intervention
Blood Pressure
Resting systolic and diastolic blood pressure will be measured using a validated automated sphygmomanometer according to standardized guidelines.
Measurements will be performed after at least 5 minutes of seated rest at baseline and after completion of the 8-week exercise intervention.
The change in systolic and diastolic blood pressure from baseline to post-intervention will be analyzed.
Measured: Baseline and end of 8-week intervention
Change in body weight
Body weight will be measured in kilograms using a calibrated digital scale at baseline and after completion of the 8-week exercise intervention.
The change in body weight from baseline to post-intervention will be analyzed.
Measured: Baseline and Week 8
Change in body mass index (BMI)
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
BMI will be assessed at baseline and after completion of the 8-week exercise intervention.
The change in BMI from baseline to post-intervention will be analyzed.
Measured: Baseline and Week 8
Change in waist circumference
Waist circumference will be measured in centimeters using a non-elastic measuring tape according to standardized procedures.
Measurements will be performed at baseline and after completion of the 8-week exercise intervention.
The change in waist circumference from baseline to post-intervention will be analyzed.
Measured: Baseline and Week 8
Change in International Physical Activity Questionnaire (IPAQ) score
Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ).
The IPAQ provides physical activity estimates expressed as metabolic equivalent task minutes per week (MET-min/week), with higher values indicating higher physical activity levels.
The questionnaire will be administered at baseline and after completion of the 8-week exercise intervention.
The change in IPAQ score from baseline to post-intervention will be analyzed.
Measured: Baseline and Week 8
Change in Hospital Anxiety and Depression Scale (HADS) scores
Anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS).
The HADS consists of 14 items and includes two subscales: anxiety (HADS-A) and depression (HADS-D), each scored from 0 to 21.
Higher scores indicate greater levels of anxiety or depressive symptoms. The questionnaire will be administered at baseline and after completion of the 8-week exercise intervention.
Changes in HADS-A and HADS-D scores from baseline to post-intervention will be analyzed.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Havva Talay Çalış
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Talay Çalış, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370363
- Sponsor's protocol ID
- KayseriCHsestrin2
- Acronym
- SES-EX
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Budanov AV, Karin M. Sestrins orchestrate cellular metabolism to attenuate aging. Cell Metab. 2013 Dec 3;18(6):792-801. doi: 10.1016/j.cmet.2013.08.018. Epub 2013 Sep 19.
PubMed 24055102Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
PubMed 30165516
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate-Intensity Continuous Exercise Versus Brisk Interval Exercise on Cardiometabolic Parameters and Sestrin-2 Levels in Hypertensive Obese Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07370363
- Acronym / sponsor ID
- SES-EX / KayseriCHsestrin2
- Conditions
- Obesity, Hypertension
- Keywords
- Hypertension, obesity, VO2max, Cardiopulmonary Exercise Testing, Sestrin-2, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Havva Talay ÇalışOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 27 Jan 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.
Obesity is a chronic and complex disease characterized by excessive fat accumulation that adversely affects health and quality of life. It is commonly accompanied by low-grade chronic systemic inflammation, which contributes to the development of insulin resistance, type 2 diabetes, dyslipidemia, hypertension, and cardiovascular diseases. Hypertension is highly prevalent among individuals with obesity, and excess body weight is a major contributor to elevated blood pressure and related cardiometabolic risk.
Regular aerobic exercise is a cornerstone of non-pharmacological management for both obesity and hypertension and has been shown to reduce chronic inflammation by downregulating pro-inflammatory pathways and upregulating anti-inflammatory mechanisms. Sestrin-2, a stress-responsive protein encoded by the SESN2 gene, has been proposed as an important regulator of metabolic homeostasis and inflammation through activation of the AMPK pathway and inhibition of NF-κB signaling. However, evidence regarding the effects of different exercise modalities on circulating Sestrin-2 levels in hypertensive obese individuals remains limited.
This prospective, randomized controlled trial aims to compare the effects of two different aerobic exercise protocols on serum Sestrin-2 levels, inflammatory status, and cardiometabolic parameters in hypertensive obese women. Cardiopulmonary exercise testing will be used to comprehensively assess cardiorespiratory fitness and physiological responses to exercise. The results of this study are expected to contribute to a better understanding of exercise-induced anti-inflammatory mechanisms and to support the development of safe, effective, and applicable exercise prescriptions for hypertensive obese women.
Detailed description
Obesity is a chronic disease associated with excessive adipose tissue accumulation and a persistent low-grade inflammatory state, which contributes to the development of cardiometabolic disorders such as hypertension, insulin resistance, dyslipidemia, and cardiovascular disease. In women, the coexistence of obesity and hypertension substantially increases morbidity and negatively affects functional capacity and quality of life. Exercise training is a cornerstone of lifestyle-based management; however, the optimal characteristics of aerobic exercise prescription and its effects on emerging molecular biomarkers remain incompletely understood.
Sestrin-2 is a stress-inducible protein encoded by the SESN2 gene and has been implicated in metabolic regulation through activation of the AMP-activated protein kinase pathway and suppression of inflammatory signaling pathways, including nuclear factor kappa B. Experimental and clinical evidence suggests that Sestrin-2 may play a protective role against obesity-related inflammation and metabolic dysfunction. Nevertheless, data regarding the modulation of circulating Sestrin-2 levels in response to different aerobic exercise modalities in hypertensive obese women are limited.
This study is designed as a prospective, randomized controlled trial including hypertensive obese women who meet predefined eligibility criteria. Participants are randomly allocated to one of two supervised aerobic exercise intervention groups: moderate-intensity continuous exercise or brisk interval exercise. Both interventions are conducted for a predefined training period under standardized conditions.
Cardiopulmonary exercise testing is performed to assess cardiorespiratory fitness and physiological responses to exercise, including maximal oxygen consumption. Blood samples are collected to measure serum Sestrin-2 levels and cardiometabolic parameters. Additional assessments include lipid profile, indices of insulin resistance, anthropometric measurements, functional capacity evaluated by the six-minute walk test, and patient-reported questionnaire outcomes.
The primary outcome measures of the study are changes in serum Sestrin-2 levels and maximal oxygen consumption. Secondary outcome measures include changes in cardiometabolic risk factors, functional capacity, and anthropometric parameters. The findings of this study are expected to provide insight into exercise-induced anti-inflammatory mechanisms and to inform evidence-based aerobic exercise prescriptions for hypertensive obese women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-Intensity Continuous Exercise | Experimental | Behavioral: Moderate-Intensity Continuous ExerciseParticipants perform supervised moderate-intensity continuous aerobic exercise at a prescribed intensity and frequency. |
| Brisk Interval Exercise | Experimental | Behavioral: Brisk Interval ExerciseParticipants perform supervised interval aerobic exercise consisting of alternating bouts of higher and moderate intensity. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female participants aged between 30 and 65 years
- Body mass index between 30.0 and <40.0 kg/m² (Class I and Class II obesity)
- Diagnosis of hypertension according to the 2018 European Society of Hypertension/European Society of Cardiology (ESH/ESC) guidelines
- Sedentary lifestyle, defined as total weekly exercise duration of less than 60 minutes
- Medically eligible for exercise participation, with approval from a Physical Medicine and Rehabilitation specialist and an Internal Medicine specialist
Key exclusion criteria (16 listed)
- Neuromuscular disorders, uncontrolled psychiatric diseases, or cognitive impairment limiting exercise participation
- Congestive heart failure, unstable angina, or acute cardiac conditions including acute myocardial infarction, acute endocarditis, myocarditis, or pericarditis
- Presence of uncontrolled systemic diseases, including:
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
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 |
|---|---|---|
| Moderate-Intensity Continuous ExerciseSupervised moderate-intensity continuous aerobic exercise performed at a prescribed intensity and frequency for the duration of the intervention period. | Behavioural | Moderate-Intensity Continuous Exercise |
| Brisk Interval ExerciseSupervised interval aerobic exercise consisting of alternating bouts of higher and moderate intensity performed throughout the intervention period. | Behavioural | Brisk Interval Exercise |
Primary outcome
Serum Sestrin-2 Level
Time frame: Baseline and end of 8-week intervention
Serum Sestrin-2 levels will be measured using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected 48 hours before the start of the 8-week exercise program and 48 hours after completion of the intervention in order to avoid the acute effects of exercise. The primary outcome is the change in Sestrin-2 levels from baseline to post-intervention.
Maximal Oxygen Consumption (VO2max)
Time frame: Baseline and end of 8-week intervention
VO2max will be assessed using cardiopulmonary exercise testing (CPET) according to standardized protocols. Measurements will be performed before the start of the exercise program and after completion of the 8-week intervention. The change in VO2max from baseline to post-intervention will be analyzed.
9 secondary outcomes
Lipid Profile
Time frame: Baseline and end of 8-week intervention
Insulin Resistance
Time frame: Baseline and end of 8-week intervention
Functional Capacity
Time frame: Baseline and end of 8-week intervention
Blood Pressure
Time frame: Baseline and end of 8-week intervention
Change in body weight
Time frame: Baseline and Week 8
Change in body mass index (BMI)
Time frame: Baseline and Week 8
Change in waist circumference
Time frame: Baseline and Week 8
Change in International Physical Activity Questionnaire (IPAQ) score
Time frame: Baseline and Week 8
Change in Hospital Anxiety and Depression Scale (HADS) scores
Time frame: Baseline and Week 8
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 27 Jan 2026.
- Background: PubMed 24055102Lee JH, Budanov AV, Karin M. Sestrins orchestrate cellular metabolism to attenuate aging. Cell Metab. 2013 Dec 3;18(6):792-801. doi: 10.1016/j.cmet.2013.08.018. Epub 2013 Sep 19.
- Background: PubMed 30165516Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Continuous Exercise and Brisk Interval Exercise in people with Obesity and Hypertension, run by Havva Talay Çalış at 1 site in Turkey (Türkiye).
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 16 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 27 Jan 2026. 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 Turkey (Türkiye). 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?
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 Rukiye AKAY, MD (+905392333789, rukiye.akay@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Sestrin-2 Level (time frame: Baseline and end of 8-week intervention). The study lists 2 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 NCT07370363, which also lists 2 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 27 Jan 2026.