Lung TransplantationNCT07660991
Evaluation of Hydroxymethylbutyrate Supplementation in Lung Transplant Candidates Receiving Pulmonary Rehabilitation
A study testing HMB in people with Lung Transplantation and Pulmoner Rehabilitation, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Lung Transplantation, Pulmoner Rehabilitation, Lun Transplant Candidates
- What is being tested?
- HMB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2025to 31 Jan 2026
- 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 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who volunteer to participate in the study,
- 40-50 years of age
- BMI: 25.0kg/m² - 29.9kg/m²
- Lung transplant candidates,
- Suitable for pulmonary rehabilitation,
- Suitable after consultation with psychiatrists, cardiologist, and orthopedists,
- Hemodynamically stable,
- Patients who have the ability to receive and follow instructions will be included.
Who cannot join
- Participants were excluded from the study if they were: • Not a lung transplant candidate
- Not Turkish-speaking
- Malnourished
- Had a chronic disease such as diabetes, hypertension, cancer, metabolic syndrome, chronic renal failure, etc.
- Were deemed ineligible after psychiatric, cardiological, or orthopedic consultations
- Pregnant or breastfeeding
Show all 10Show fewer
- Used any oral nutritional supplement containing HMB before the study
- Ineligible for pulmonary rehabilitation for any reason
- Were found to be non-compliant with dietary/supplement interventions during follow-up after inclusion in the study.
- Participants could withdraw from the study at any time during the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koşuyolu Yüksek Ihtisas Eğitim Ve Araştırma Hastanesi
Istanbul, Kartal, 34865
About this study
Official title: Pulmoner Rehabilitasyon Alan akciğer Nakil adaylarında hidroksimetilbütirat Takviyesinin değerlendirilmesi
Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. It is important to optimize the nutritional status of patients during the waiting period before transplantation, to positively improve their vital functions such as exercise capacity, to get up as soon as possible after transplantation, to shorten the hospitalization process and to support survival. Pulmonary rehabilitation (PR) aims to prevent further progression of respiratory disease and improve the physical and mental health of patients, as well as helping patients to adopt healthy behavior habits. PR before transplantation helps individuals maintain or optimize their functional status before surgery. PR before transplantation helps individuals maintain or optimize their functional status before surgery. Beta-hydroxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine. Several studies have shown HMB supplements to be beneficial, either alone or in combination with other amino acids and exercise training, for maintaining and restoring lean body mass, muscle strength and function in older adults. HMB provides a decrease in muscle protein breakdown along with an increase in muscle protein synthesis. In addition, it stimulates muscle protein synthesis by activating the mechanical target of the mammals are the target of rapamycin (mTOR) system and growth hormone/insulin-like growth hormone. Given the very low amounts of HMB and the low conversion rate of leucine to HMB (5-10%), the optimal dose requirement of HMB cannot be met with a standard diet. Therefore, oral supplementation of HMB is seen as an alternative to alleviate adult metabolic diseases, muscle wasting and functional loss. In lung transplant candidates, it is important to optimize nutrition and health conditions during the listing period, to get up as soon as possible after transplantation, to shorten the hospitalization process and to support survival. The study aimed to investigate the positive/negative effects of pulmonary rehabilitation and HMB supplementation, which supports muscle mass and protein production, on patients compared to pulmonary rehabilitation alone in lung transplant candidates.
Read the detailed description
Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Primary indications for lung transplantation in the world are; 34% chronic obstructive pulmonary disease (COPD), 24% idiopathic pulmonary fibrosis (IPF), 17% cystic fibrosis (CF), 6% alpha-1-antitrypsin deficiency, 3% idiopathic pulmonary arterial hypertension (IPAH), 4% pulmonary fibrous (non-IPF), 3% bronchiectasis, 2.6% re transplantation and 2.5% of them are classified as sarcoidosis. Absolute contraindications for lung transplantation are; active malignancy, coronary artery disease without revascularization ability, significant extrapulmonary organ dysfunction, active tobacco or bad substance use, the presence of extremely serious active infections such as tuberculosis, morbid obesity and lack of psychosocial support. Absolute contraindications for lung transplantation are; active malignancy, coronary artery disease without revascularization ability, significant extrapulmonary organ dysfunction, active tobacco or bad substance use, the presence of extremely serious active infections such as tuberculosis, morbid obesity and lack of psychosocial support. Some relative contraindications are critical illness, mechanical ventilation (MV) and extracorporeal membrane oxygenation (ECMO) support, each transplant center has a different attitude. The upper age limit for lung transplantation varies according to each center, but is generally accepted as between 70 and 75 years of age. Beta-hydroxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine.roxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine. HMB is found in very small amounts in some foods such as avocados, citrus fruits, caulidroxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine. HMB is found in very small amounts in some foods such as avocados, citrus fruits, cauliflower and catfish. Leucine has a specific role in the regulation and control of protein synthesis in muscle cells. About 5% of leucine in the body is converted into HMB. Many studies have shown that HMB supplements alone or in combination with other amino acids and in combination with exercise training are beneficial for maintaining and restoring lean body mass, muscle strength and function in older adults. Many studies have shown that HMB supplements alone or in combination with other amino acids and in combination with exercise training are beneficial for maintaining and restoring lean body mass, muscle strength and function in older adults. Leucine is the most effective branched chain amino acid in important cellular processes such as protein synthesis and energy metabolism. The first step in leucine metabolism in the body is the reversible transamination that occurs in skeletal muscles to form α-ketoisocaproate with simultaneous production of glutarate from α-ketoglutarate. The first step in leucine metabolism in the body is the reversible transamination that occurs in skeletal muscles to form α-ketoisocaproate with simultaneous production of glutarate from α-ketoglutarate. The second stage is the irreversible oxidative decarboxylation of α-ketoisocaproate by branched-chain α-keto acid dehydrogenase (BCKD) and α-ketoisocaproate dehydrogenase (KICD) enzymes. In liver mitochondria, 90% of the α-ketoisocaproate produced causes the formation of acetoacetate and acetyl CoA, while in liver cytosol, the remaining 5-10% α-ketoisocaproate is oxidized to HMB by the enzyme KICD. Liver mitochondria, 90% of the α-ketoisocaproate produced causes the formation of acetoacetate and acetyl CoA, while in liver cytosol, the remaining 5-10% α-ketoisocaproate is oxidized to HMB by the enzyme KICD. HMB provides a decrease in muscle protein breakdown along with an increase in muscle protein synthesis. In addition, it stimulates muscle protein synthesis by activating the mechanical target of the rapamyc November (mTOR) system and growth hormone/insulin-like growth hormone. HMB has also been shown to be associated with a decrease in muscle proteolysis by inhibiting the ubiquitin-proteasome and autophagy-lysosome systems. Given the very low amounts of HMB present in foods and the low conversion rate of leucine to HMB (5-10%), optimal HMB dose requirements cannot be met with a standard diet. Therefore, oral HMB supplementation is considered an alternative to alleviate adult metabolic diseases, muscle wasting, and functional loss. Pulmonary rehabilitation (PR) aims to prevent further progression of respiratory disease and improve patients' physical and mental health, while also encouraging patients to adopt healthy behavioral habits. The European Respiratory Society and the American Thoracic Society define PR as "patient-specific treatments, including but not limited to exercise training and behavior modification, designed to improve the physical and psychological well-being of individuals with chronic respiratory diseases and to promote long-term health-promoting behaviors." PR, which includes exercise training, is a powerful intervention designed to improve exercise tolerance, skeletal and respiratory muscle function, movement efficiency, symptoms of dyspnea and fatigue, and health-related quality of life. PR aims to stabilize or reverse the pathophysiological and psychopathological symptoms of the disease and strives to restore the patient to the highest possible functional capacity. The optimal exercise type, duration, intensity, and frequency for PR have not yet been determined. A minimum of eight weeks is generally recommended for PR programs to provide lasting benefits to the patient. Exercise sessions are generally scheduled 3-5 times a week, each session lasting 20-45 minutes. It is suggested that the improvement mechanism of exercise training is related to increasing aerobic capacity and peripheral muscle performance in patients. Exercise intolerance and decreased quality of life often persist after transplantation. Physiological changes associated with severe chronic lung disease, extremity muscle dysfunction, inactivity/deconditioning, and nutritional deficiencies can affect exercise capacity and physical functioning in lung transplant candidates. Prolonged post-transplant hospital and intensive care unit stays, prolonged immobilization, immunosuppressant medications, and organ rejection can all impact lung recipients' recovery in terms of exercise tolerance and quality of life. Decreases in muscle mass and quadriceps strength are frequently observed in the pre-transplant period and have been reported to persist for up to 3 years post-transplant. Pre-transplant PR helps individuals maintain or optimize their pre-operative functional status. The nutritional status of patients on the waiting list is associated with post-transplant survival. Studies have identified obesity, low body mass index, and low serum albumin concentration as significant risk factors for increased mortality after lung transplantation. Nutritional status in lung transplant candidates is associated with post-transplant survival. Obesity, as well as pre-transplant malnutrition, is considered a contraindication and appears to increase the risk of post-transplant mortality independently of other risk factors. Lean body mass (FFM) is an important indicator of nutritional status. It is associated with muscle mass, muscle function, lung function, and quality of life. A decrease in FFM is significantly associated with increased mortality while waiting for transplantation and prolonged intensive care unit stay after transplantation. Body mass index (BMI) is a parameter used to assess nutritional status, calculated by dividing body mass by the square of height in meters. The resulting BMI is evaluated according to the World Health Organization (WHO) classification. A BMI above 30 kg/m² or below 18.5 kg/m² has been shown to increase post-transplant mortality and primary graft dysfunction. Furthermore, low albumin levels have frequently been associated with adverse post-transplant outcomes. In patients with end-stage lung disease, significant loss of lung function, respiratory failure, recurrent infections, decreased appetite caused by hypoxia and depression, and gastrointestinal dysfunction all contribute to inadequate energy intake and, consequently, malnutrition and even cachexia. The various complications associated with malnutrition lead to increased frequency and duration of hospitalization and shortened survival after transplantation. Therefore, it is crucial to assess the nutritional status of lung transplant candidates before transplantation, identify any risks of malnutrition in a timely manner, and provide an individualized nutrition program tailored to each patient. Optimizing nutrition and health status in lung transplant candidates during the listing period is crucial for achieving recovery as quickly as possible after transplantation, shortening hospital stays, and promoting survival. The study aimed to investigate the positive/negative effects of pulmonary rehabilitation and HMB supplementation, which supports muscle mass and protein synthesis, compared to pulmonary rehabilitation alone in lung transplant candidates.
- Being tested
- HMB
- Keywords
- lung transplantation, pulmonary rehabilitation, lung transplant candidates, hydroxymethylbutyrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMBDietary supplement
Participants of half will be given hydroxymethylbutyrate for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| hmb arm | Experimental | Participants of half will be given hydroxymethylbutyrate for 2 months. all participants will take pulmonary rehabilitation. Receives: Dietary Supplement: HMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' biochemical measurements fasting glucose was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. Fasting blood sugar is usually measured after 8-10 hours of fasting, and the normal range is 70-99 mg/dL.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participiants' 6-minute walk test was evaluated at the begining of the study and at the end of the 8-week study. The 6-minute walk test was performed by a physiotherapist from the lung transplant team. The normal distance for a 6-minute walking test is between 400-700m.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comporasion of lung transplant candidates who received pulmonary rehabilitation, dietary therapy abd hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' respiratory function tests (FEV1, FVC AND FEV1/FVC) was evaluated at the begining of the study and at the end of the 8-week study. A pulmonary function test was performed by a nurse working at Koşuyolu High Specialization Training and Research Hospital. FEV1 and FVC values of 80% or higher are considered normal. The FEV1/FVC ratio is normally between 70% and 80%.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' body composition (weight (kilograms), height (meters), BMI (kg/m2)) was assessed at the beginning of the study and at the end of the 8-week study using a BC-420MA body analyzer and measuring tape. BMI is by dividing weight (kilograms) by the square of height (meters). Individuals with a BMI between 25.0 and 29.9kg/m2 were accepted.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' short form -36 (SF-36) quality of life scale was evaluated at the beginning of the study and at the end of the 8-week study. SF-36 quality of life scale scores were evaluated and compared at the beginning and end of the study. Higher scores on the SF-36 scale indicate a better quality of life. The score ranges from a minimum of zero to a maximum of one hundred points.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' biochemical measurements (total protein, prealbumin, albumin) was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. The normal range for total serum protein is 6.0 to 8.3 g/dl. The normal range for prealbumin is 15-36 mg/dl. The normal range for serum albumin is 34-54 mg/dl.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy
Participants' biochemical measurements (urea, creatinine) was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. The normal range for serum urea is 10-50 mg/dl. The normal serum creatinine range is 0.5-1.1 mg/dl for women and 0.6-1.2 mg/dl for men.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' biochemical measurements (total cholesterol, triglyceride) was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. The normal value for serum total cholesterol should be below 200 mg/dl. The normal value for serum total triglycerides should be below 150 mg/dl.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' body composition (lean body mass (FFM), body fat percentage, body muscle mass, body fat mass) was assessed at the beginning of the study and at the end of the 8-week study using a BC-420MA body analyzer and measuring tape. The normal FFM value should be 75-85% for women and 80-90% for men. The normal range for body fat percentage is 25-31% for women and 18-24% for men.
Measured: From the registration stage to the end of the 8-week follow-up period.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Participants' body composition (waistcircumference, hip circumference, waist-to-hip ratio, upper mid-arm circumference, calf circumference) was assessed at the beginning of the study and at the end of the 8-week study using a measuring tape. Waist circumference should be below 80cm for women and 94cm for men. A waist-to-hip ratio of 0.85 or less is considered normal for women, and 0.90 or less for men. An upper mid-arm circumference of 22cm or more is considered normal for women, and 23cm or more for men. A calf circumference of 31-36 cm is considered normal for women, and 35-38 cm for men.
Measured: From the registration stage to the end of the 8-week follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start10 Jun 2025
- Primary completion30 Sep 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study was designed as a randomized controlled trial. The study consisted of control and experimental groups, including participants receiving Diet+PR and Diet+PR+HMB. Participants' inclusion groups will be determined by a draw. All participants who met the study inclusion criteria will provide informed consent and will be administered a sociodemographic questionnaire, a 24-hour food intake record, the NRS2002 form, the sf-36 quality of life scale, anthropometric measurements, biochemical measurements, the 6MWT, the PFT, and a handgrip strength test. Each participating patient will participate in a PR program with a physical therapist, consisting of 45-minute sessions, three days a week, for eight weeks. Each patient will be provided with a diet plan and training tailored to their needs.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Öztürk, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660991
- Sponsor's protocol ID
- OkanU-MO-1
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duan Y, Li F, Li Y, Tang Y, Kong X, Feng Z, Anthony TG, Watford M, Hou Y, Wu G, Yin Y. The role of leucine and its metabolites in protein and energy metabolism. Amino Acids. 2016 Jan;48(1):41-51. doi: 10.1007/s00726-015-2067-1. Epub 2015 Aug 9.
PubMed 26255285Ding Q, Chen W, Chen C, Zhu YM, Yang WW, Ding JR. Evaluation of nutritional status in lung transplant recipients and its correlation with post-transplant short-term prognosis: a retrospective study. Ann Transl Med. 2022 Jul;10(14):793. doi: 10.21037/atm-22-3125.
PubMed 35965836Courel-Ibanez J, Vetrovsky T, Dadova K, Pallares JG, Steffl M. Health Benefits of beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation in Addition to Physical Exercise in Older Adults: A Systematic Review with Meta-Analysis. Nutrients. 2019 Sep 3;11(9):2082. doi: 10.3390/nu11092082.
PubMed 31484462Cornelison SD, Pascual RM. Pulmonary Rehabilitation in the Management of Chronic Lung Disease. Med Clin North Am. 2019 May;103(3):577-584. doi: 10.1016/j.mcna.2018.12.015.
PubMed 30955523Chicago Universitesi Pritzker Tip Fakultesi, Gogus Hastaliklari ve Yogun Bakim Bilim Dali, Chicago, ABD, & Bag, R. (2020). General Indications and Patient Selection in Lung Transplantation. Güncel Göğüs Hastalıkları Serisi, 8(1), 20-31. https://doi.org/10.5152/gghs.2020.002
Arjuna A, Olson MT, Walia R. Current trends in candidate selection, contraindications, and indications for lung transplantation. J Thorac Dis. 2021 Nov;13(11):6514-6527. doi: 10.21037/jtd-2021-09.
PubMed 34992831Wouters EFM, Wouters BBREF, Augustin IML, Houben-Wilke S, Vanfleteren LEGW, Franssen FME. Personalised pulmonary rehabilitation in COPD. Eur Respir Rev. 2018 Mar 28;27(147):170125. doi: 10.1183/16000617.0125-2017. Print 2018 Mar 31.
PubMed 29592864Tuncay, F. (2021). Pulmoner rehabilitasyon. Journal of Physical Medicine and Rehabilitation Sciences, 24(2):169-179.
Troosters T, Janssens W, Demeyer H, Rabinovich RA. Pulmonary rehabilitation and physical interventions. Eur Respir Rev. 2023 Jun 7;32(168):220222. doi: 10.1183/16000617.0222-2022. Print 2023 Jun 30.
PubMed 37286219Suzuki H, Yoshino I. A narrative review on the management of patients awaiting lung transplantation in Japan. J Thorac Dis. 2023 Oct 31;15(10):5856-5862. doi: 10.21037/jtd-22-1690. Epub 2023 Oct 20.
PubMed 37969266Prado CM, Orsso CE, Pereira SL, Atherton PJ, Deutz NEP. Effects of beta-hydroxy beta-methylbutyrate (HMB) supplementation on muscle mass, function, and other outcomes in patients with cancer: a systematic review. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1623-1641. doi: 10.1002/jcsm.12952. Epub 2022 Mar 17.
PubMed 35301826Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
PubMed 16264058National Institutes of Health (NIH), National Cancer Institute (NCI). Dietary Assessment Primer. 24-hour Dietary Recall (24HR) At a Glance. Bethesda, MD: National Cancer Institute (2014).
Molfino A, Gioia G, Rossi Fanelli F, Muscaritoli M. Beta-hydroxy-beta-methylbutyrate supplementation in health and disease: a systematic review of randomized trials. Amino Acids. 2013 Dec;45(6):1273-92. doi: 10.1007/s00726-013-1592-z. Epub 2013 Sep 22.
PubMed 24057808Makhdami N, Farooqi M, Thom-Fernandes C, Raghavan NG. Pulmonary rehabilitation in interstitial lung diseases. Curr Opin Pulm Med. 2020 Sep;26(5):470-476. doi: 10.1097/MCP.0000000000000700.
PubMed 32769674
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmoner Rehabilitasyon Alan akciğer Nakil adaylarında hidroksimetilbütirat Takviyesinin değerlendirilmesi
- ClinicalTrials.gov ID
- NCT07660991
- Acronym / sponsor ID
- OkanU-MO-1
- Keywords
- lung transplantation, pulmonary rehabilitation, lung transplant candidates, hydroxymethylbutyrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 22 Jun 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.
Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. It is important to optimize the nutritional status of patients during the waiting period before transplantation, to positively improve their vital functions such as exercise capacity, to get up as soon as possible after transplantation, to shorten the hospitalization process and to support survival. Pulmonary rehabilitation (PR) aims to prevent further progression of respiratory disease and improve the physical and mental health of patients, as well as helping patients to adopt healthy behavior habits. PR before transplantation helps individuals maintain or optimize their functional status before surgery. PR before transplantation helps individuals maintain or optimize their functional status before surgery. Beta-hydroxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine. Several studies have shown HMB supplements to be beneficial, either alone or in combination with other amino acids and exercise training, for maintaining and restoring lean body mass, muscle strength and function in older adults. HMB provides a decrease in muscle protein breakdown along with an increase in muscle protein synthesis. In addition, it stimulates muscle protein synthesis by activating the mechanical target of the mammals are the target of rapamycin (mTOR) system and growth hormone/insulin-like growth hormone. Given the very low amounts of HMB and the low conversion rate of leucine to HMB (5-10%), the optimal dose requirement of HMB cannot be met with a standard diet. Therefore, oral supplementation of HMB is seen as an alternative to alleviate adult metabolic diseases, muscle wasting and functional loss. In lung transplant candidates, it is important to optimize nutrition and health conditions during the listing period, to get up as soon as possible after transplantation, to shorten the hospitalization process and to support survival. The study aimed to investigate the positive/negative effects of pulmonary rehabilitation and HMB supplementation, which supports muscle mass and protein production, on patients compared to pulmonary rehabilitation alone in lung transplant candidates.
Detailed description
Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Lung transplantation (LTx) is an accepted treatment option for patients with end-stage lung disease who do not respond to non-transplant treatments. Primary indications for lung transplantation in the world are; 34% chronic obstructive pulmonary disease (COPD), 24% idiopathic pulmonary fibrosis (IPF), 17% cystic fibrosis (CF), 6% alpha-1-antitrypsin deficiency, 3% idiopathic pulmonary arterial hypertension (IPAH), 4% pulmonary fibrous (non-IPF), 3% bronchiectasis, 2.6% re transplantation and 2.5% of them are classified as sarcoidosis. Absolute contraindications for lung transplantation are; active malignancy, coronary artery disease without revascularization ability, significant extrapulmonary organ dysfunction, active tobacco or bad substance use, the presence of extremely serious active infections such as tuberculosis, morbid obesity and lack of psychosocial support. Absolute contraindications for lung transplantation are; active malignancy, coronary artery disease without revascularization ability, significant extrapulmonary organ dysfunction, active tobacco or bad substance use, the presence of extremely serious active infections such as tuberculosis, morbid obesity and lack of psychosocial support. Some relative contraindications are critical illness, mechanical ventilation (MV) and extracorporeal membrane oxygenation (ECMO) support, each transplant center has a different attitude. The upper age limit for lung transplantation varies according to each center, but is generally accepted as between 70 and 75 years of age. Beta-hydroxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine.roxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine. HMB is found in very small amounts in some foods such as avocados, citrus fruits, caulidroxy-beta-methylbutyrate (HMB) is an active metabolite of the branched-chain essential amino acid leucine. HMB is found in very small amounts in some foods such as avocados, citrus fruits, cauliflower and catfish. Leucine has a specific role in the regulation and control of protein synthesis in muscle cells. About 5% of leucine in the body is converted into HMB. Many studies have shown that HMB supplements alone or in combination with other amino acids and in combination with exercise training are beneficial for maintaining and restoring lean body mass, muscle strength and function in older adults. Many studies have shown that HMB supplements alone or in combination with other amino acids and in combination with exercise training are beneficial for maintaining and restoring lean body mass, muscle strength and function in older adults. Leucine is the most effective branched chain amino acid in important cellular processes such as protein synthesis and energy metabolism. The first step in leucine metabolism in the body is the reversible transamination that occurs in skeletal muscles to form α-ketoisocaproate with simultaneous production of glutarate from α-ketoglutarate. The first step in leucine metabolism in the body is the reversible transamination that occurs in skeletal muscles to form α-ketoisocaproate with simultaneous production of glutarate from α-ketoglutarate. The second stage is the irreversible oxidative decarboxylation of α-ketoisocaproate by branched-chain α-keto acid dehydrogenase (BCKD) and α-ketoisocaproate dehydrogenase (KICD) enzymes. In liver mitochondria, 90% of the α-ketoisocaproate produced causes the formation of acetoacetate and acetyl CoA, while in liver cytosol, the remaining 5-10% α-ketoisocaproate is oxidized to HMB by the enzyme KICD. Liver mitochondria, 90% of the α-ketoisocaproate produced causes the formation of acetoacetate and acetyl CoA, while in liver cytosol, the remaining 5-10% α-ketoisocaproate is oxidized to HMB by the enzyme KICD. HMB provides a decrease in muscle protein breakdown along with an increase in muscle protein synthesis. In addition, it stimulates muscle protein synthesis by activating the mechanical target of the rapamyc November (mTOR) system and growth hormone/insulin-like growth hormone. HMB has also been shown to be associated with a decrease in muscle proteolysis by inhibiting the ubiquitin-proteasome and autophagy-lysosome systems. Given the very low amounts of HMB present in foods and the low conversion rate of leucine to HMB (5-10%), optimal HMB dose requirements cannot be met with a standard diet. Therefore, oral HMB supplementation is considered an alternative to alleviate adult metabolic diseases, muscle wasting, and functional loss. Pulmonary rehabilitation (PR) aims to prevent further progression of respiratory disease and improve patients' physical and mental health, while also encouraging patients to adopt healthy behavioral habits. The European Respiratory Society and the American Thoracic Society define PR as "patient-specific treatments, including but not limited to exercise training and behavior modification, designed to improve the physical and psychological well-being of individuals with chronic respiratory diseases and to promote long-term health-promoting behaviors." PR, which includes exercise training, is a powerful intervention designed to improve exercise tolerance, skeletal and respiratory muscle function, movement efficiency, symptoms of dyspnea and fatigue, and health-related quality of life. PR aims to stabilize or reverse the pathophysiological and psychopathological symptoms of the disease and strives to restore the patient to the highest possible functional capacity. The optimal exercise type, duration, intensity, and frequency for PR have not yet been determined. A minimum of eight weeks is generally recommended for PR programs to provide lasting benefits to the patient. Exercise sessions are generally scheduled 3-5 times a week, each session lasting 20-45 minutes. It is suggested that the improvement mechanism of exercise training is related to increasing aerobic capacity and peripheral muscle performance in patients. Exercise intolerance and decreased quality of life often persist after transplantation. Physiological changes associated with severe chronic lung disease, extremity muscle dysfunction, inactivity/deconditioning, and nutritional deficiencies can affect exercise capacity and physical functioning in lung transplant candidates. Prolonged post-transplant hospital and intensive care unit stays, prolonged immobilization, immunosuppressant medications, and organ rejection can all impact lung recipients' recovery in terms of exercise tolerance and quality of life. Decreases in muscle mass and quadriceps strength are frequently observed in the pre-transplant period and have been reported to persist for up to 3 years post-transplant. Pre-transplant PR helps individuals maintain or optimize their pre-operative functional status. The nutritional status of patients on the waiting list is associated with post-transplant survival. Studies have identified obesity, low body mass index, and low serum albumin concentration as significant risk factors for increased mortality after lung transplantation. Nutritional status in lung transplant candidates is associated with post-transplant survival. Obesity, as well as pre-transplant malnutrition, is considered a contraindication and appears to increase the risk of post-transplant mortality independently of other risk factors. Lean body mass (FFM) is an important indicator of nutritional status. It is associated with muscle mass, muscle function, lung function, and quality of life. A decrease in FFM is significantly associated with increased mortality while waiting for transplantation and prolonged intensive care unit stay after transplantation. Body mass index (BMI) is a parameter used to assess nutritional status, calculated by dividing body mass by the square of height in meters. The resulting BMI is evaluated according to the World Health Organization (WHO) classification. A BMI above 30 kg/m² or below 18.5 kg/m² has been shown to increase post-transplant mortality and primary graft dysfunction. Furthermore, low albumin levels have frequently been associated with adverse post-transplant outcomes. In patients with end-stage lung disease, significant loss of lung function, respiratory failure, recurrent infections, decreased appetite caused by hypoxia and depression, and gastrointestinal dysfunction all contribute to inadequate energy intake and, consequently, malnutrition and even cachexia. The various complications associated with malnutrition lead to increased frequency and duration of hospitalization and shortened survival after transplantation. Therefore, it is crucial to assess the nutritional status of lung transplant candidates before transplantation, identify any risks of malnutrition in a timely manner, and provide an individualized nutrition program tailored to each patient. Optimizing nutrition and health status in lung transplant candidates during the listing period is crucial for achieving recovery as quickly as possible after transplantation, shortening hospital stays, and promoting survival. The study aimed to investigate the positive/negative effects of pulmonary rehabilitation and HMB supplementation, which supports muscle mass and protein synthesis, compared to pulmonary rehabilitation alone in lung transplant candidates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study was designed as a randomized controlled trial. The study consisted of control and experimental groups, including participants receiving Diet+PR and Diet+PR+HMB. Participants' inclusion groups will be determined by a draw. All participants who met the study inclusion criteria will provide informed consent and will be administered a sociodemographic questionnaire, a 24-hour food intake record, the NRS2002 form, the sf-36 quality of life scale, anthropometric measurements, biochemical measurements, the 6MWT, the PFT, and a handgrip strength test. Each participating patient will participate in a PR program with a physical therapist, consisting of 45-minute sessions, three days a week, for eight weeks. Each patient will be provided with a diet plan and training tailored to their needs.
| Arm | Type | Receives |
|---|---|---|
| hmb arm | Experimental | Dietary Supplement: HMBParticipants of half will be given hydroxymethylbutyrate for 2 months. all participants will take pulmonary rehabilitation. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients who volunteer to participate in the study,
Key exclusion criteria (10 listed)
- Participants were excluded from the study if they were: • Not a lung transplant candidate
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 |
|---|---|---|
| HMBParticipants of half will be given hydroxymethylbutyrate for 2 months. | Dietary supplement | hmb arm |
Primary outcome
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' biochemical measurements fasting glucose was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. Fasting blood sugar is usually measured after 8-10 hours of fasting, and the normal range is 70-99 mg/dL.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participiants' 6-minute walk test was evaluated at the begining of the study and at the end of the 8-week study. The 6-minute walk test was performed by a physiotherapist from the lung transplant team. The normal distance for a 6-minute walking test is between 400-700m.
Comporasion of lung transplant candidates who received pulmonary rehabilitation, dietary therapy abd hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' respiratory function tests (FEV1, FVC AND FEV1/FVC) was evaluated at the begining of the study and at the end of the 8-week study. A pulmonary function test was performed by a nurse working at Koşuyolu High Specialization Training and Research Hospital. FEV1 and FVC values of 80% or higher are considered normal. The FEV1/FVC ratio is normally between 70% and 80%.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' body composition (weight (kilograms), height (meters), BMI (kg/m2)) was assessed at the beginning of the study and at the end of the 8-week study using a BC-420MA body analyzer and measuring tape. BMI is by dividing weight (kilograms) by the square of height (meters). Individuals with a BMI between 25.0 and 29.9kg/m2 were accepted.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' short form -36 (SF-36) quality of life scale was evaluated at the beginning of the study and at the end of the 8-week study. SF-36 quality of life scale scores were evaluated and compared at the beginning and end of the study. Higher scores on the SF-36 scale indicate a better quality of life. The score ranges from a minimum of zero to a maximum of one hundred points.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' biochemical measurements (total protein, prealbumin, albumin) was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. The normal range for total serum protein is 6.0 to 8.3 g/dl. The normal range for prealbumin is 15-36 mg/dl. The normal range for serum albumin is 34-54 mg/dl.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' biochemical measurements (urea, creatinine) was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. The normal range for serum urea is 10-50 mg/dl. The normal serum creatinine range is 0.5-1.1 mg/dl for women and 0.6-1.2 mg/dl for men.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' biochemical measurements (total cholesterol, triglyceride) was evaluated at the beginning of the study and at the end of the 8-week study. The samples were evaluated in the laboratory of Koşuyolu High Specialization Training and Research Hospital. The normal value for serum total cholesterol should be below 200 mg/dl. The normal value for serum total triglycerides should be below 150 mg/dl.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' body composition (lean body mass (FFM), body fat percentage, body muscle mass, body fat mass) was assessed at the beginning of the study and at the end of the 8-week study using a BC-420MA body analyzer and measuring tape. The normal FFM value should be 75-85% for women and 80-90% for men. The normal range for body fat percentage is 25-31% for women and 18-24% for men.
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy.
Time frame: From the registration stage to the end of the 8-week follow-up period.
Participants' body composition (waistcircumference, hip circumference, waist-to-hip ratio, upper mid-arm circumference, calf circumference) was assessed at the beginning of the study and at the end of the 8-week study using a measuring tape. Waist circumference should be below 80cm for women and 94cm for men. A waist-to-hip ratio of 0.85 or less is considered normal for women, and 0.90 or less for men. An upper mid-arm circumference of 22cm or more is considered normal for women, and 23cm or more for men. A calf circumference of 31-36 cm is considered normal for women, and 35-38 cm for men.
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 22 Jun 2026.
- Background: PubMed 26255285Duan Y, Li F, Li Y, Tang Y, Kong X, Feng Z, Anthony TG, Watford M, Hou Y, Wu G, Yin Y. The role of leucine and its metabolites in protein and energy metabolism. Amino Acids. 2016 Jan;48(1):41-51. doi: 10.1007/s00726-015-2067-1. Epub 2015 Aug 9.
- Background: PubMed 35965836Ding Q, Chen W, Chen C, Zhu YM, Yang WW, Ding JR. Evaluation of nutritional status in lung transplant recipients and its correlation with post-transplant short-term prognosis: a retrospective study. Ann Transl Med. 2022 Jul;10(14):793. doi: 10.21037/atm-22-3125.
- Background: PubMed 31484462Courel-Ibanez J, Vetrovsky T, Dadova K, Pallares JG, Steffl M. Health Benefits of beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation in Addition to Physical Exercise in Older Adults: A Systematic Review with Meta-Analysis. Nutrients. 2019 Sep 3;11(9):2082. doi: 10.3390/nu11092082.
- Background: PubMed 30955523Cornelison SD, Pascual RM. Pulmonary Rehabilitation in the Management of Chronic Lung Disease. Med Clin North Am. 2019 May;103(3):577-584. doi: 10.1016/j.mcna.2018.12.015.
- BackgroundChicago Universitesi Pritzker Tip Fakultesi, Gogus Hastaliklari ve Yogun Bakim Bilim Dali, Chicago, ABD, & Bag, R. (2020). General Indications and Patient Selection in Lung Transplantation. Güncel Göğüs Hastalıkları Serisi, 8(1), 20-31. https://doi.org/10.5152/gghs.2020.002
- Background: PubMed 34992831Arjuna A, Olson MT, Walia R. Current trends in candidate selection, contraindications, and indications for lung transplantation. J Thorac Dis. 2021 Nov;13(11):6514-6527. doi: 10.21037/jtd-2021-09.
- Background: PubMed 29592864Wouters EFM, Wouters BBREF, Augustin IML, Houben-Wilke S, Vanfleteren LEGW, Franssen FME. Personalised pulmonary rehabilitation in COPD. Eur Respir Rev. 2018 Mar 28;27(147):170125. doi: 10.1183/16000617.0125-2017. Print 2018 Mar 31.
- BackgroundTuncay, F. (2021). Pulmoner rehabilitasyon. Journal of Physical Medicine and Rehabilitation Sciences, 24(2):169-179.
- Background: PubMed 37286219Troosters T, Janssens W, Demeyer H, Rabinovich RA. Pulmonary rehabilitation and physical interventions. Eur Respir Rev. 2023 Jun 7;32(168):220222. doi: 10.1183/16000617.0222-2022. Print 2023 Jun 30.
- Background: PubMed 37969266Suzuki H, Yoshino I. A narrative review on the management of patients awaiting lung transplantation in Japan. J Thorac Dis. 2023 Oct 31;15(10):5856-5862. doi: 10.21037/jtd-22-1690. Epub 2023 Oct 20.
- Background: PubMed 35301826Prado CM, Orsso CE, Pereira SL, Atherton PJ, Deutz NEP. Effects of beta-hydroxy beta-methylbutyrate (HMB) supplementation on muscle mass, function, and other outcomes in patients with cancer: a systematic review. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1623-1641. doi: 10.1002/jcsm.12952. Epub 2022 Mar 17.
- Background: PubMed 16264058Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. 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. 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 HMB in people with Lung Transplantation and Pulmoner Rehabilitation, run by Okan University 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 8 inclusion and 10 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 22 Jun 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?
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?
Comparison of lung transplant candidates who received pulmonary rehabilitation, dietary therapy, and hydroxymethylbutyrate for 8 weeks with those who received only pulmonary rehabilitation and dietary therapy. (time frame: From the registration stage to the end of the 8-week follow-up period.). The study lists 10 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 NCT07660991, which also lists 24 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 22 Jun 2026.