CitrullineNCT05143879
Long-Term Effect of Combined Citrulline and Nitrate-Rich Beetroot Extract Supplementation
A study testing Citrulline, Nitrate and Nitrate plus Citrulline in people with Citrulline and Nitrate, run by Burgos Nutrition at 1 site in Spain.
Trial summary
Citrulline (CIT) and nitrate-rich beetroot extract (BEET) are widely studied ergogenic aids. However, both supplements have been studied in sort-term and isolated. To the best of the authors' knowledge, the effects of combining both supplements on exercise-induced muscle damage (EIMD) and hormone status have not been… Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Citrulline, Nitrate, Athletes
- What is being tested?
- Citrulline, Nitrate and Nitrate plus Citrulline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Oct 2021
- 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 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males between 25 and 35 years old
- Triathletes
- With at least 5 years of experience
- Without any disease
- Non smokers
- Non drinkers of alcohol
- Not to take any other medications or stimulant substances during the study
- 2 weeks without taking other nutritional supplements
Who cannot join
- Men under 25 and over 35 years of age.
- Non triathletes
- Less than 5 years of experience
- With any disease
- Smokers
- Alcohol drinkers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effect of Combined Citrulline and Nitrate-rich Beetroot Extract Supplementation on Recovery Status in Trained Male Triathletes
Citrulline (CIT) and nitrate-rich beetroot extract (BEET) are widely studied ergogenic aids. However, both supplements have been studied in sort-term and isolated. To the best of the authors' knowledge, the effects of combining both supplements on exercise-induced muscle damage (EIMD) and hormone status have not been investigated to date. Therefore, the main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone, cortisol and Testosterone cortisol ratio (T/C)) in male trained triathletes. This study was a double-blind, placebo-controlled trial where participants (n = 32) were randomized into 4 different groups: placebo group (PLG; n = 8), CIT group (CITG; 3 g/day of CIT; n = 8), BEET group (BEETG; 2.1 g/day of BEET (300 mg/day of NIT) ; n = 8) and CIT-NIT group (CIT-BEETG; 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT); n = 8). Blood samples were collected from all participants at baseline (T1) and after 9 weeks of supplementation (T2).
Read the detailed description
Triathlon is an endurance sport in which athletes compete sequentially in swimming, cycling and running. Prolonged and strenuous training combined with insufficient recovery can produce muscular and metabolic stress, resulting in structural and functional damage to the musculoskeletal system leading to a fatigue status, which results in decreased athletic performance. As a consequence of this type of combined exercise, there are also alterations in biochemical markers of exercise-induced muscle damage (EIMD) as well as anabolic/catabolic hormones. Therefore, their analysis is useful in determining the balance between training loads and recovery. In this sense, it is essential to include different strategies to reduce or prevent EIMD, which delay or reduce muscle fatigue and improve sports performance. One of these strategies is the use of different ergogenic aids such as L-citrulline (CIT) and nitrates (NIT) which have been proposed as both substances produce an increase in nitric oxide (NO).
- Conditions
- Citrulline, Nitrate, Athletes
- Being tested
- Citrulline, Nitrate, Nitrate plus Citrulline, Placebo
- Keywords
- triathlon, performance, ergogenic aids, muscle fatigue, recovery, hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitrullineDietary supplement
3 g/day during 9 weeks
NitrateDietary supplement
300 mg/day during 9 weeks
Nitrate plus CitrullineDietary supplement
3 g/day of citrulline and 300 mg/day of nitrate during 9 weeks
PlaceboDietary supplement
Also called Cellulose
3 g/day during 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 8 subjects took 3 g/kg/day of placebo during 9 weeks Receives: Dietary Supplement: Placebo |
| Nitrate | Active comparator | 8 subjects took 3 g/kg/day of nitrate during 9 weeks Receives: Dietary Supplement: Nitrate |
| Citrulline | Active comparator | 8 subjects took 3 g/kg/day of citrulline during 9 weeks Receives: Dietary Supplement: Citrulline |
| Nitrate plus Citrulline | Active comparator | 8 subjects took 3 g/kg/day of nitrate plus citrulline during 9 weeks Receives: Dietary Supplement: Nitrate plus Citrulline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol
μg/dL
Measured: 9 weeks
Testosterone
ng/mL
Measured: 9 weeks
Testosterone to cortisol ratio
ng/mL
Measured: 9 weeks
Urea
mg/dl
Measured: 9 weeks
Creatinine
mg/dl
Measured: 9 weeks
AST
U/L
Measured: 9 weeks
ALT
U/L
Measured: 9 weeks
GGT
U/L
Measured: 9 weeks
LDH
U/L
Measured: 9 weeks
CK
U/L
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 May 2018
- Primary completion30 Aug 2018
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for CitrullineStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CM plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone (T), cortisol (C), and T/C) in male trained triathletes.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burgos Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de León, University of the Basque Country (UPV/EHU), University of Valladolid
- Responsible party
- Principal investigator, Jose Burgos Balmaseda, Burgos Nutrition
- Investigators
- Jose Burgos Balmaseda, Graduate, Principal investigator, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143879
- Sponsor's protocol ID
- ULE-020-2020
- Status last verified
- Nov 2021
- First submitted
- 2 Oct 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez AM, Trexler ET. Effects of Citrulline Supplementation on Exercise Performance in Humans: A Review of the Current Literature. J Strength Cond Res. 2020 May;34(5):1480-1495. doi: 10.1519/JSC.0000000000003426.
PubMed 31977835Gilligan DM, Panza JA, Kilcoyne CM, Waclawiw MA, Casino PR, Quyyumi AA. Contribution of endothelium-derived nitric oxide to exercise-induced vasodilation. Circulation. 1994 Dec;90(6):2853-8. doi: 10.1161/01.cir.90.6.2853.
PubMed 7994830Anderson JE. A role for nitric oxide in muscle repair: nitric oxide-mediated activation of muscle satellite cells. Mol Biol Cell. 2000 May;11(5):1859-74. doi: 10.1091/mbc.11.5.1859.
PubMed 10793157Bailey SJ, Blackwell JR, Lord T, Vanhatalo A, Winyard PG, Jones AM. l-Citrulline supplementation improves O2 uptake kinetics and high-intensity exercise performance in humans. J Appl Physiol (1985). 2015 Aug 15;119(4):385-95. doi: 10.1152/japplphysiol.00192.2014. Epub 2015 May 28.
PubMed 26023227Viribay A, Arribalzaga S, Mielgo-Ayuso J, Castaneda-Babarro A, Seco-Calvo J, Urdampilleta A. Effects of 120 g/h of Carbohydrates Intake during a Mountain Marathon on Exercise-Induced Muscle Damage in Elite Runners. Nutrients. 2020 May 11;12(5):1367. doi: 10.3390/nu12051367.
PubMed 32403259Wang JM, Gu CH, Tao L, Wu XL. Effect of surgery and efferent duct ligation on testicular blood flow and testicular steroidogenesis in the rat. J Reprod Fertil. 1985 Jan;73(1):191-6. doi: 10.1530/jrf.0.0730191.
PubMed 3968652Monau TR, Vargas VE, Zhang L, Myers DA, Ducsay CA. Nitric oxide inhibits ACTH-induced cortisol production in near-term, long-term hypoxic ovine fetal adrenocortical cells. Reprod Sci. 2010 Oct;17(10):955-62. doi: 10.1177/1933719110376092. Epub 2010 Aug 16.
PubMed 20713972Milton-Laskibar I, Martinez JA, Portillo MP. Current Knowledge on Beetroot Bioactive Compounds: Role of Nitrate and Betalains in Health and Disease. Foods. 2021 Jun 7;10(6):1314. doi: 10.3390/foods10061314.
PubMed 34200431Clifford T, Bell O, West DJ, Howatson G, Stevenson EJ. The effects of beetroot juice supplementation on indices of muscle damage following eccentric exercise. Eur J Appl Physiol. 2016 Feb;116(2):353-62. doi: 10.1007/s00421-015-3290-x. Epub 2015 Nov 4.
PubMed 26537365Garnacho-Castano MV, Palau-Salva G, Serra-Paya N, Ruiz-Hermosel M, Berbell M, Vinals X, Bataller MG, Carbonell T, Vilches-Saez S, Cobo EP, Molina-Raya L. Understanding the effects of beetroot juice intake on CrossFit performance by assessing hormonal, metabolic and mechanical response: a randomized, double-blind, crossover design. J Int Soc Sports Nutr. 2020 Nov 13;17(1):56. doi: 10.1186/s12970-020-00388-z.
PubMed 33187518da Silva DK, Jacinto JL, de Andrade WB, Roveratti MC, Estoche JM, Balvedi MCW, de Oliveira DB, da Silva RA, Aguiar AF. Citrulline Malate Does Not Improve Muscle Recovery after Resistance Exercise in Untrained Young Adult Men. Nutrients. 2017 Oct 18;9(10):1132. doi: 10.3390/nu9101132.
PubMed 29057836Wax B, Kavazis AN, Luckett W. Effects of Supplemental Citrulline-Malate Ingestion on Blood Lactate, Cardiovascular Dynamics, and Resistance Exercise Performance in Trained Males. J Diet Suppl. 2016;13(3):269-82. doi: 10.3109/19390211.2015.1008615. Epub 2015 Feb 12.
PubMed 25674699Perez-Guisado J, Jakeman PM. Citrulline malate enhances athletic anaerobic performance and relieves muscle soreness. J Strength Cond Res. 2010 May;24(5):1215-22. doi: 10.1519/JSC.0b013e3181cb28e0.
PubMed 20386132McMahon NF, Leveritt MD, Pavey TG. The Effect of Dietary Nitrate Supplementation on Endurance Exercise Performance in Healthy Adults: A Systematic Review and Meta-Analysis. Sports Med. 2017 Apr;47(4):735-756. doi: 10.1007/s40279-016-0617-7.
PubMed 27600147Jones AM, Thompson C, Wylie LJ, Vanhatalo A. Dietary Nitrate and Physical Performance. Annu Rev Nutr. 2018 Aug 21;38:303-328. doi: 10.1146/annurev-nutr-082117-051622.
PubMed 30130468
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Combined Citrulline and Nitrate-rich Beetroot Extract Supplementation on Recovery Status in Trained Male Triathletes
- ClinicalTrials.gov ID
- NCT05143879
- Acronym / sponsor ID
- ULE-020-2020
- Conditions
- Citrulline, Nitrate, Athletes
- Keywords
- triathlon, performance, ergogenic aids, muscle fatigue, recovery, hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Burgos NutritionUniversity, hospital or other
- Collaborators
- Universidad de León, University of the Basque Country (UPV/EHU), University of Valladolid
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 3 Dec 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.
Citrulline (CIT) and nitrate-rich beetroot extract (BEET) are widely studied ergogenic aids. However, both supplements have been studied in sort-term and isolated. To the best of the authors' knowledge, the effects of combining both supplements on exercise-induced muscle damage (EIMD) and hormone status have not been investigated to date. Therefore, the main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone, cortisol and Testosterone cortisol ratio (T/C)) in male trained triathletes. This study was a double-blind, placebo-controlled trial where participants (n = 32) were randomized into 4 different groups: placebo group (PLG; n = 8), CIT group (CITG; 3 g/day of CIT; n = 8), BEET group (BEETG; 2.1 g/day of BEET (300 mg/day of NIT) ; n = 8) and CIT-NIT group (CIT-BEETG; 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT); n = 8). Blood samples were collected from all participants at baseline (T1) and after 9 weeks of supplementation (T2).
Detailed description
Triathlon is an endurance sport in which athletes compete sequentially in swimming, cycling and running. Prolonged and strenuous training combined with insufficient recovery can produce muscular and metabolic stress, resulting in structural and functional damage to the musculoskeletal system leading to a fatigue status, which results in decreased athletic performance. As a consequence of this type of combined exercise, there are also alterations in biochemical markers of exercise-induced muscle damage (EIMD) as well as anabolic/catabolic hormones. Therefore, their analysis is useful in determining the balance between training loads and recovery. In this sense, it is essential to include different strategies to reduce or prevent EIMD, which delay or reduce muscle fatigue and improve sports performance. One of these strategies is the use of different ergogenic aids such as L-citrulline (CIT) and nitrates (NIT) which have been proposed as both substances produce an increase in nitric oxide (NO).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- The main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CM plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone (T), cortisol (C), and T/C) in male trained triathletes.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo8 subjects took 3 g/kg/day of placebo during 9 weeks |
| Nitrate | Active comparator | Dietary Supplement: Nitrate8 subjects took 3 g/kg/day of nitrate during 9 weeks |
| Citrulline | Active comparator | Dietary Supplement: Citrulline8 subjects took 3 g/kg/day of citrulline during 9 weeks |
| Nitrate plus Citrulline | Active comparator | Dietary Supplement: Nitrate plus Citrulline8 subjects took 3 g/kg/day of nitrate plus citrulline during 9 weeks |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males between 25 and 35 years old
- Triathletes
- With at least 5 years of experience
- Without any disease
- Non smokers
Key exclusion criteria (6 listed)
- Men under 25 and over 35 years of age.
- Non triathletes
- Less than 5 years of experience
- With any disease
- Smokers
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 |
|---|---|---|
| Citrulline3 g/day during 9 weeks | Dietary supplement | Citrulline |
| Nitrate300 mg/day during 9 weeks | Dietary supplement | Nitrate |
| Nitrate plus Citrulline3 g/day of citrulline and 300 mg/day of nitrate during 9 weeks | Dietary supplement | Nitrate plus Citrulline |
| PlaceboAlso: Cellulose3 g/day during 9 weeks | Dietary supplement | Placebo |
Primary outcome
Cortisol
Time frame: 9 weeks
μg/dL
Testosterone
Time frame: 9 weeks
ng/mL
Testosterone to cortisol ratio
Time frame: 9 weeks
ng/mL
Urea
Time frame: 9 weeks
mg/dl
Creatinine
Time frame: 9 weeks
mg/dl
AST
Time frame: 9 weeks
U/L
ALT
Time frame: 9 weeks
U/L
GGT
Time frame: 9 weeks
U/L
LDH
Time frame: 9 weeks
U/L
CK
Time frame: 9 weeks
U/L
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 3 Dec 2021.
- Results publication: PubMed 31977835Gonzalez AM, Trexler ET. Effects of Citrulline Supplementation on Exercise Performance in Humans: A Review of the Current Literature. J Strength Cond Res. 2020 May;34(5):1480-1495. doi: 10.1519/JSC.0000000000003426.
- Results publication: PubMed 7994830Gilligan DM, Panza JA, Kilcoyne CM, Waclawiw MA, Casino PR, Quyyumi AA. Contribution of endothelium-derived nitric oxide to exercise-induced vasodilation. Circulation. 1994 Dec;90(6):2853-8. doi: 10.1161/01.cir.90.6.2853.
- Results publication: PubMed 10793157Anderson JE. A role for nitric oxide in muscle repair: nitric oxide-mediated activation of muscle satellite cells. Mol Biol Cell. 2000 May;11(5):1859-74. doi: 10.1091/mbc.11.5.1859.
- Results publication: PubMed 26023227Bailey SJ, Blackwell JR, Lord T, Vanhatalo A, Winyard PG, Jones AM. l-Citrulline supplementation improves O2 uptake kinetics and high-intensity exercise performance in humans. J Appl Physiol (1985). 2015 Aug 15;119(4):385-95. doi: 10.1152/japplphysiol.00192.2014. Epub 2015 May 28.
- Results publication: PubMed 32403259Viribay A, Arribalzaga S, Mielgo-Ayuso J, Castaneda-Babarro A, Seco-Calvo J, Urdampilleta A. Effects of 120 g/h of Carbohydrates Intake during a Mountain Marathon on Exercise-Induced Muscle Damage in Elite Runners. Nutrients. 2020 May 11;12(5):1367. doi: 10.3390/nu12051367.
- Results publication: PubMed 3968652Wang JM, Gu CH, Tao L, Wu XL. Effect of surgery and efferent duct ligation on testicular blood flow and testicular steroidogenesis in the rat. J Reprod Fertil. 1985 Jan;73(1):191-6. doi: 10.1530/jrf.0.0730191.
- Results publication: PubMed 20713972Monau TR, Vargas VE, Zhang L, Myers DA, Ducsay CA. Nitric oxide inhibits ACTH-induced cortisol production in near-term, long-term hypoxic ovine fetal adrenocortical cells. Reprod Sci. 2010 Oct;17(10):955-62. doi: 10.1177/1933719110376092. Epub 2010 Aug 16.
- Results publication: PubMed 34200431Milton-Laskibar I, Martinez JA, Portillo MP. Current Knowledge on Beetroot Bioactive Compounds: Role of Nitrate and Betalains in Health and Disease. Foods. 2021 Jun 7;10(6):1314. doi: 10.3390/foods10061314.
- Results publication: PubMed 26537365Clifford T, Bell O, West DJ, Howatson G, Stevenson EJ. The effects of beetroot juice supplementation on indices of muscle damage following eccentric exercise. Eur J Appl Physiol. 2016 Feb;116(2):353-62. doi: 10.1007/s00421-015-3290-x. Epub 2015 Nov 4.
- Results publication: PubMed 33187518Garnacho-Castano MV, Palau-Salva G, Serra-Paya N, Ruiz-Hermosel M, Berbell M, Vinals X, Bataller MG, Carbonell T, Vilches-Saez S, Cobo EP, Molina-Raya L. Understanding the effects of beetroot juice intake on CrossFit performance by assessing hormonal, metabolic and mechanical response: a randomized, double-blind, crossover design. J Int Soc Sports Nutr. 2020 Nov 13;17(1):56. doi: 10.1186/s12970-020-00388-z.
- Results publication: PubMed 29057836da Silva DK, Jacinto JL, de Andrade WB, Roveratti MC, Estoche JM, Balvedi MCW, de Oliveira DB, da Silva RA, Aguiar AF. Citrulline Malate Does Not Improve Muscle Recovery after Resistance Exercise in Untrained Young Adult Men. Nutrients. 2017 Oct 18;9(10):1132. doi: 10.3390/nu9101132.
- Results publication: PubMed 25674699Wax B, Kavazis AN, Luckett W. Effects of Supplemental Citrulline-Malate Ingestion on Blood Lactate, Cardiovascular Dynamics, and Resistance Exercise Performance in Trained Males. J Diet Suppl. 2016;13(3):269-82. doi: 10.3109/19390211.2015.1008615. Epub 2015 Feb 12.
- 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.
Jose Burgos Balmaseda, Graduate principal investigator
Universidad de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrulline, Nitrate and Nitrate plus Citrulline in people with Citrulline and Nitrate, run by Burgos Nutrition at 1 site in Spain.
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 6 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 3 Dec 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Cortisol (time frame: 9 weeks). 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 NCT05143879, which also lists 20 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 3 Dec 2021.