ObesityNCT05055154
Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD
A study testing Very low calorie diet in people with Obesity and Weight Loss, run by Special Hospital for Extended Treatment of Duga Resa at 1 site in Croatia.
Trial summary
Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Weight Loss, DNA Damage
- What is being tested?
- Very low calorie diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCroatia
- Study dates
- 14 Jun 2019to 3 Nov 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index ≥ 35 kg/m2
Who cannot join
- pregnancy
- actual tumor diseases
- recent diagnostic or treatment exposures to ionizing radiation in the period of one year
- individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Special Hospital for Extended Treatment of Duga Resa
Duga Resa, 47250
About this study
Official title: Oxidative Stress and L-CBMN Cytome Assay Parameters Levels in Severely Obese With BMI ≥ 35kg/m2 After 3 Weeks 567 kcal Hospital Controlled VLCD
Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.
Read the detailed description
Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric parameters.
- Conditions
- Obesity, Weight Loss, DNA Damage
- Being tested
- Very low calorie diet
- Keywords
- Obesity, Very low calorie diet, Oxidative stress, Micronuclei, apoptosis
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low calorie dietDevice
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Very low calorie diet | Experimental | Use of very low calorie diet prepared in the hospital Receives: Device: Very low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in body mass index
Body mass index is calculated by dividing body mass (kg) with square of body height (m)
Measured: Baseline, after 3 weeks of VLCD
The changes in the body fat mass
Body fat mass (kg) assessed with bioelectrical impedance method
Measured: Baseline, after 3 weeks of VLCD
The changes in the skeletal muscle mass
Skeletal muscle mass (kg) assessed with bioelectrical impedance method
Measured: Baseline, after 3 weeks of VLCD
The changes in the percent body fat
Percent body fat (%) assessed with bioelectrical impedance method
Measured: Baseline, after 3 weeks of VLCD
The changes in fasting glucose concentration
Concentration of glucose (mmol/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in urea concentration
Concentration of urea (mmol/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in lipid profile
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in insulin concentration
Concentration of insulin (mIU/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in homeostatic model assessment (HOMA) index
HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5
Measured: Baseline, after 3 weeks of VLCD
The changes in inflammation parameters
Concentration of C-reactive protein (mg/L) and total white blood cell count
Measured: Baseline, after 3 weeks of VLCD
Secondary outcomes (2)
The changes in oxidative stress
Concentration of glutathione (RFU) and reactive oxygen species (RFU)
Measured: Baseline, after 3 weeks of VLCD
The changes in DNA damage
Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes
Measured: Baseline, after 3 weeks of VLCD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start14 Jun 2019
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Special Hospital for Extended Treatment of Duga Resa
- Sponsor type
- Other government
- Collaborators
- Institute for Medical Research and Occupational Health, University of Zagreb
- Responsible party
- Sponsor
- Investigators
- Mirta Milic, PhD, Principal investigator, Institute for Medical Research and Occupational HealthDragan Bozcevic, Doctor, Principal investigator, Special Hospital for Extended Treatment of Duga ResaAna-Marija Domijan, Prof., Principal investigator, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055154
- Sponsor's protocol ID
- OSMN35aVLCD-26
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grindel A, Brath H, Nersesyan A, Knasmueller S, Wagner KH. Association of Genomic Instability with HbA1c levels and Medication in Diabetic Patients. Sci Rep. 2017 Feb 2;7:41985. doi: 10.1038/srep41985.
PubMed 28150817Franzke B, Schwingshackl L, Wagner KH. Chromosomal damage measured by the cytokinesis block micronucleus cytome assay in diabetes and obesity - A systematic review and meta-analysis. Mutat Res Rev Mutat Res. 2020 Oct-Dec;786:108343. doi: 10.1016/j.mrrev.2020.108343. Epub 2020 Nov 2.
PubMed 33339574Mulligan AA, Luben RN, Bhaniani A, Parry-Smith DJ, O'Connor L, Khawaja AP, Forouhi NG, Khaw KT; EPIC-Norfolk FFQ Study. A new tool for converting food frequency questionnaire data into nutrient and food group values: FETA research methods and availability. BMJ Open. 2014 Mar 27;4(3):e004503. doi: 10.1136/bmjopen-2013-004503.
PubMed 24674997Kamencic H, Lyon A, Paterson PG, Juurlink BH. Monochlorobimane fluorometric method to measure tissue glutathione. Anal Biochem. 2000 Nov 1;286(1):35-7. doi: 10.1006/abio.2000.4765.
PubMed 11038270Kalyanaraman B, Darley-Usmar V, Davies KJ, Dennery PA, Forman HJ, Grisham MB, Mann GE, Moore K, Roberts LJ 2nd, Ischiropoulos H. Measuring reactive oxygen and nitrogen species with fluorescent probes: challenges and limitations. Free Radic Biol Med. 2012 Jan 1;52(1):1-6. doi: 10.1016/j.freeradbiomed.2011.09.030. Epub 2011 Oct 2.
PubMed 22027063Ustundag B, Gungor S, Aygun AD, Turgut M, Yilmaz E. Oxidative status and serum leptin levels in obese prepubertal children. Cell Biochem Funct. 2007 Sep-Oct;25(5):479-83. doi: 10.1002/cbf.1334.
PubMed 16874844Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
PubMed 15599400Keaney JF Jr, Larson MG, Vasan RS, Wilson PW, Lipinska I, Corey D, Massaro JM, Sutherland P, Vita JA, Benjamin EJ; Framingham Study. Obesity and systemic oxidative stress: clinical correlates of oxidative stress in the Framingham Study. Arterioscler Thromb Vasc Biol. 2003 Mar 1;23(3):434-9. doi: 10.1161/01.ATV.0000058402.34138.11. Epub 2003 Jan 30.
PubMed 12615693Il'yasova D, Wang F, Spasojevic I, Base K, D'Agostino RB Jr, Wagenknecht LE. Racial differences in urinary F2-isoprostane levels and the cross-sectional association with BMI. Obesity (Silver Spring). 2012 Oct;20(10):2147-50. doi: 10.1038/oby.2012.170. Epub 2012 Jun 22.
PubMed 22836686Kobayashi H, Matsuda M, Fukuhara A, Komuro R, Shimomura I. Dysregulated glutathione metabolism links to impaired insulin action in adipocytes. Am J Physiol Endocrinol Metab. 2009 Jun;296(6):E1326-34. doi: 10.1152/ajpendo.90921.2008. Epub 2009 Apr 14.
PubMed 19366877Tormos KV, Anso E, Hamanaka RB, Eisenbart J, Joseph J, Kalyanaraman B, Chandel NS. Mitochondrial complex III ROS regulate adipocyte differentiation. Cell Metab. 2011 Oct 5;14(4):537-44. doi: 10.1016/j.cmet.2011.08.007.
PubMed 21982713Won HY, Sohn JH, Min HJ, Lee K, Woo HA, Ho YS, Park JW, Rhee SG, Hwang ES. Glutathione peroxidase 1 deficiency attenuates allergen-induced airway inflammation by suppressing Th2 and Th17 cell development. Antioxid Redox Signal. 2010 Sep 1;13(5):575-87. doi: 10.1089/ars.2009.2989.
PubMed 20367278Bozinovski S, Seow HJ, Crack PJ, Anderson GP, Vlahos R. Glutathione peroxidase-1 primes pro-inflammatory cytokine production after LPS challenge in vivo. PLoS One. 2012;7(3):e33172. doi: 10.1371/journal.pone.0033172. Epub 2012 Mar 6.
PubMed 22412999Picklo MJ, Long EK, Vomhof-DeKrey EE. Glutathionyl systems and metabolic dysfunction in obesity. Nutr Rev. 2015 Dec;73(12):858-68. doi: 10.1093/nutrit/nuv042. Epub 2015 Oct 22.
PubMed 26493322Setayesh T, Misik M, Langie SAS, Godschalk R, Waldherr M, Bauer T, Leitner S, Bichler C, Prager G, Krupitza G, Haslberger A, Knasmuller S. Impact of Weight Loss Strategies on Obesity-Induced DNA Damage. Mol Nutr Food Res. 2019 Sep;63(17):e1900045. doi: 10.1002/mnfr.201900045. Epub 2019 Jun 14.
PubMed 31141317
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and L-CBMN Cytome Assay Parameters Levels in Severely Obese With BMI ≥ 35kg/m2 After 3 Weeks 567 kcal Hospital Controlled VLCD
- ClinicalTrials.gov ID
- NCT05055154
- Acronym / sponsor ID
- OSMN35aVLCD-26
- Conditions
- Obesity, Weight Loss, DNA Damage
- Keywords
- Obesity, Very low calorie diet, Oxidative stress, Micronuclei, apoptosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Special Hospital for Extended Treatment of Duga ResaOther government
- Collaborators
- Institute for Medical Research and Occupational Health, University of Zagreb
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 24 Sep 2021 (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 leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.
Detailed description
Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very low calorie diet | Experimental | Device: Very low calorie dietUse of very low calorie diet prepared in the hospital |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- body mass index ≥ 35 kg/m2
Key exclusion criteria (4 listed)
- pregnancy
- actual tumor diseases
- recent diagnostic or treatment exposures to ionizing radiation in the period of one year
- individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
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 |
|---|---|---|
| Very low calorie dietIn hospital patients will eat prepared diet with 567 kcal a day during 3 weeks | Device | Very low calorie diet |
Primary outcome
The changes in body mass index
Time frame: Baseline, after 3 weeks of VLCD
Body mass index is calculated by dividing body mass (kg) with square of body height (m)
The changes in the body fat mass
Time frame: Baseline, after 3 weeks of VLCD
Body fat mass (kg) assessed with bioelectrical impedance method
The changes in the skeletal muscle mass
Time frame: Baseline, after 3 weeks of VLCD
Skeletal muscle mass (kg) assessed with bioelectrical impedance method
The changes in the percent body fat
Time frame: Baseline, after 3 weeks of VLCD
Percent body fat (%) assessed with bioelectrical impedance method
The changes in fasting glucose concentration
Time frame: Baseline, after 3 weeks of VLCD
Concentration of glucose (mmol/L)
The changes in urea concentration
Time frame: Baseline, after 3 weeks of VLCD
Concentration of urea (mmol/L)
The changes in lipid profile
Time frame: Baseline, after 3 weeks of VLCD
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
The changes in insulin concentration
Time frame: Baseline, after 3 weeks of VLCD
Concentration of insulin (mIU/L)
The changes in homeostatic model assessment (HOMA) index
Time frame: Baseline, after 3 weeks of VLCD
HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5
The changes in inflammation parameters
Time frame: Baseline, after 3 weeks of VLCD
Concentration of C-reactive protein (mg/L) and total white blood cell count
2 secondary outcomes
The changes in oxidative stress
Time frame: Baseline, after 3 weeks of VLCD
The changes in DNA damage
Time frame: Baseline, after 3 weeks of VLCD
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 24 Sep 2021.
- Background: PubMed 28150817Grindel A, Brath H, Nersesyan A, Knasmueller S, Wagner KH. Association of Genomic Instability with HbA1c levels and Medication in Diabetic Patients. Sci Rep. 2017 Feb 2;7:41985. doi: 10.1038/srep41985.
- Background: PubMed 33339574Franzke B, Schwingshackl L, Wagner KH. Chromosomal damage measured by the cytokinesis block micronucleus cytome assay in diabetes and obesity - A systematic review and meta-analysis. Mutat Res Rev Mutat Res. 2020 Oct-Dec;786:108343. doi: 10.1016/j.mrrev.2020.108343. Epub 2020 Nov 2.
- Background: PubMed 24674997Mulligan AA, Luben RN, Bhaniani A, Parry-Smith DJ, O'Connor L, Khawaja AP, Forouhi NG, Khaw KT; EPIC-Norfolk FFQ Study. A new tool for converting food frequency questionnaire data into nutrient and food group values: FETA research methods and availability. BMJ Open. 2014 Mar 27;4(3):e004503. doi: 10.1136/bmjopen-2013-004503.
- Background: PubMed 11038270Kamencic H, Lyon A, Paterson PG, Juurlink BH. Monochlorobimane fluorometric method to measure tissue glutathione. Anal Biochem. 2000 Nov 1;286(1):35-7. doi: 10.1006/abio.2000.4765.
- Background: PubMed 22027063Kalyanaraman B, Darley-Usmar V, Davies KJ, Dennery PA, Forman HJ, Grisham MB, Mann GE, Moore K, Roberts LJ 2nd, Ischiropoulos H. Measuring reactive oxygen and nitrogen species with fluorescent probes: challenges and limitations. Free Radic Biol Med. 2012 Jan 1;52(1):1-6. doi: 10.1016/j.freeradbiomed.2011.09.030. Epub 2011 Oct 2.
- Background: PubMed 16874844Ustundag B, Gungor S, Aygun AD, Turgut M, Yilmaz E. Oxidative status and serum leptin levels in obese prepubertal children. Cell Biochem Funct. 2007 Sep-Oct;25(5):479-83. doi: 10.1002/cbf.1334.
- Background: PubMed 15599400Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
- Background: PubMed 12615693Keaney JF Jr, Larson MG, Vasan RS, Wilson PW, Lipinska I, Corey D, Massaro JM, Sutherland P, Vita JA, Benjamin EJ; Framingham Study. Obesity and systemic oxidative stress: clinical correlates of oxidative stress in the Framingham Study. Arterioscler Thromb Vasc Biol. 2003 Mar 1;23(3):434-9. doi: 10.1161/01.ATV.0000058402.34138.11. Epub 2003 Jan 30.
- Background: PubMed 22836686Il'yasova D, Wang F, Spasojevic I, Base K, D'Agostino RB Jr, Wagenknecht LE. Racial differences in urinary F2-isoprostane levels and the cross-sectional association with BMI. Obesity (Silver Spring). 2012 Oct;20(10):2147-50. doi: 10.1038/oby.2012.170. Epub 2012 Jun 22.
- Background: PubMed 19366877Kobayashi H, Matsuda M, Fukuhara A, Komuro R, Shimomura I. Dysregulated glutathione metabolism links to impaired insulin action in adipocytes. Am J Physiol Endocrinol Metab. 2009 Jun;296(6):E1326-34. doi: 10.1152/ajpendo.90921.2008. Epub 2009 Apr 14.
- Background: PubMed 21982713Tormos KV, Anso E, Hamanaka RB, Eisenbart J, Joseph J, Kalyanaraman B, Chandel NS. Mitochondrial complex III ROS regulate adipocyte differentiation. Cell Metab. 2011 Oct 5;14(4):537-44. doi: 10.1016/j.cmet.2011.08.007.
- Background: PubMed 20367278Won HY, Sohn JH, Min HJ, Lee K, Woo HA, Ho YS, Park JW, Rhee SG, Hwang ES. Glutathione peroxidase 1 deficiency attenuates allergen-induced airway inflammation by suppressing Th2 and Th17 cell development. Antioxid Redox Signal. 2010 Sep 1;13(5):575-87. doi: 10.1089/ars.2009.2989.
- 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.
Mirta Milic, PhD principal investigator
Institute for Medical Research and Occupational Health
Dragan Bozcevic, Doctor principal investigator
Special Hospital for Extended Treatment of Duga Resa
Ana-Marija Domijan, Prof. principal investigator
University of Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low calorie diet in people with Obesity and Weight Loss, run by Special Hospital for Extended Treatment of Duga Resa at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 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 24 Sep 2021. 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 Croatia. 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?
The changes in body mass index (time frame: Baseline, after 3 weeks of VLCD). 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 NCT05055154, which also lists 17 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 24 Sep 2021.