DehydrationNCT05768789
Buoy Electrolyte Study on Hydration Status of Active Men and Women
A study testing Buoy Electrolyte, Water only and Nuun Electrolyte in people with Dehydration and Electrolyte Imbalance, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Buoy is an all-natural, organic, FDA compliant dietary electrolyte supplement that can be dissolved in 8-12oz water (or other liquid) and provide electrolytes in servings of 1/3 teaspoon. This study will evaluate Buoy in hydrating active adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Electrolyte Imbalance, Electrolyte Depletion
- What is being tested?
- Buoy Electrolyte, Water only and Nuun Electrolyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2023to 27 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, >18 to 45 years of age
- Freely given written consent
- Non-tobacco users
- Negative pregnancy test in women of childbearing potential
- BMI < 35 kg/m2
- GFR > 60 ml/min
Show all 12Show fewer
- No known underlying medical condition
- Willing to refrain from EtOH for 24h prior to test day
- Willing to refrain from strenuous exercise for 24 h prior to each test day
- Acceptable to have one 8oz cup of coffee/liquid on the morning of the test, but must be consistent each visit
- Without active infection of any kind
- Engaged in exercise three or more hours per week
Who cannot join
- Abnormal creatinine (Cr > 1.2).
- Proteinuria / hematuria / glucosuria based on urine dipstick.
- Diagnosed medical condition that would impede results (CHF, HTN, CAD, CKD, history of electrolyte abnormality).
- Pregnancy
- Use of diuretics within past 2 weeks
- Obesity (BMI > 35)
- Active infection based on symptoms (bacterial or viral)
- Hemodynamic abnormality at screening visit: Blood pressure less than 100/60 or greater than 140/90.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 152132
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Impact of Buoy on Hydration Status of Active Men and Women
Buoy is an all-natural, organic, FDA compliant dietary electrolyte supplement that can be dissolved in 8-12oz water (or other liquid) and provide electrolytes in servings of 1/3 teaspoon. This study will evaluate Buoy in hydrating active adults.
Read the detailed description
Prior to initiation of the study, participants will have a screening visit to complete informed consent and health history. The history for females will include their last date for menstruation and/or birth control method to take into consideration the effects of ovulation on water retention. During this visit we will measure heart rate, blood pressure, height, weight. Females will be administered a urine pregnancy test.
Participants must refrain from vigorous exercise within 24 hours of study visit. Participants will fast (food) overnight for 10h prior to initiation of test. Upon waking they are asked to empty their bowel \& bladder. They can consume one 8oz cup of coffee or other liquid. They will present at 7-8am at which time they will be asked to empty their bladder again. After resting for 5 minutes baseline vitals will be taken, including blood pressure, heart rate, weight, bioimpedance. Urinalysis dipstick for protein/blood/glucose and i-STAT measurement for creatinine and electrolytes on Visit 1 to confirm eligibility. For Visit 2 and Visit 3, the participant will be asked to review medical history and any change in status may warrant an additional baseline creatinine and blood/protein test to confirm eligibility. Additional food or beverage will not be allowed throughout the study period. All studies will be repeated in the same subject using either Buoy (intervention) or water (control) or Nuun (intervention). Urine will be collected at four specific timepoints during the intervention and the volume will be recorded. If participants need to urinate between scheduled collection times, urine will be collected, volume recorded, and combined with the urine collection of the following timepoint. These urine samples will be measured and a fraction of it will be sent to the lab to be tested for the following electrolytes: sodium, potassium, chloride and urine osmolarity. Urine creatinine will also be tested at these timepoints.
- Conditions
- Dehydration, Electrolyte Imbalance, Electrolyte Depletion, Fluid and Electrolyte Imbalance
- Being tested
- Buoy Electrolyte, Water only, Nuun Electrolyte
- Keywords
- dehydration, electrolyte, electrolyte supplement, electrolyte loss, electrolyte ingestion, hydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buoy ElectrolyteDietary supplement
Each subject consumed Beverage 1 (Buoy Hydration Drops) at a dose containing 600 mg/L of Na+ over 4 hours while measuring urine output over 6 hours.
Water onlyOther
Each subjected ingested 1 L of Kirkland® bottled water at a rate of 6.25% of the total amount of water every 15 minutes for four hours
Nuun ElectrolyteDietary supplement
Each subject consumed 1 L of water with two dissolved Nuun® Sport Hydration tabs (Nuun, Seattle, WA), containing 600 mg of sodium, over 30 minutes (2 equal volumes every 15 minutes) while measuring urine output over 6 hours (
| Study group | Role | What they receive |
|---|---|---|
| Buoy Electrolyte then Water only then Nuun Electrolyte | Experimental | Visit 1: Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours. The goal is to give 600mg of Na+ over 4 hours while measuring urine output over 6 hours. Therefore, to safely achieve a total dose 600mg Na+ (6-fold increase from single dose) we will use 4 tsps (18 ml) of Buoy diluted in 1 L of water.
Visit 2: Water serves as a control. Participants will ingest the same quantity of water (1 L) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours.
Visit 3: Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight. The goal is to give a one-time dose of Nuun (600mg Na+) at the start of the trial, diluted in 1L water to be consumed within 30 min (similar to prior published data, Pence 2020). Receives: Dietary Supplement: Buoy Electrolyte; Other: Water only; Dietary Supplement: Nuun Electrolyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Fluid Balance
Determined by subtracting the cumulative urine output from the total fluid load consumed
Measured: 360 minutes after ingestion
Electrolytes in Urine
Sodium levels will be measured
Measured: Urine will be measured during each visit (three total visits that each last 6 hours)
Urine Osmolarity (mOsm/kg)
Osmolarity measures the concentration of solutes in urine. This is a key indicator of how concentrated or diluted the urine is, which directly reflects hydration status and kidney function. This can fluctuate depending on how much water the kidneys are excreting or retaining.
Measured: 360 minutes after ingestion
Secondary outcomes (1)
Bio Impedance
Bio impedance measured through difference in body fat % pre- and post-urine
Measured: 360-minutes after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start13 Sep 2023
- Primary completion27 Apr 2024
- Study completion27 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the interventions in the same order one after the other on different days (Buoy, then Water, then Nuun) to complete the 3 arms of the study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harikesh Subramanian, University of Pittsburgh
- Investigators
- Harikesh Subramanian, MBBS, Principal investigator, UPMC Department of Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768789
- Sponsor's protocol ID
- STUDY22090018
- Status last verified
- May 2025
- First submitted
- 25 Oct 2022
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perrier ET. Shifting Focus: From Hydration for Performance to Hydration for Health. Ann Nutr Metab. 2017;70 Suppl 1:4-12. doi: 10.1159/000462996. Epub 2017 Jun 15.
PubMed 28614817Liska D, Mah E, Brisbois T, Barrios PL, Baker LB, Spriet LL. Narrative Review of Hydration and Selected Health Outcomes in the General Population. Nutrients. 2019 Jan 1;11(1):70. doi: 10.3390/nu11010070.
PubMed 30609670Popkin BM, D'Anci KE, Rosenberg IH. Water, hydration, and health. Nutr Rev. 2010 Aug;68(8):439-58. doi: 10.1111/j.1753-4887.2010.00304.x.
PubMed 20646222Nuccio RP, Barnes KA, Carter JM, Baker LB. Fluid Balance in Team Sport Athletes and the Effect of Hypohydration on Cognitive, Technical, and Physical Performance. Sports Med. 2017 Oct;47(10):1951-1982. doi: 10.1007/s40279-017-0738-7.
PubMed 28508338Von Duvillard SP, Braun WA, Markofski M, Beneke R, Leithauser R. Fluids and hydration in prolonged endurance performance. Nutrition. 2004 Jul-Aug;20(7-8):651-6. doi: 10.1016/j.nut.2004.04.011.
PubMed 15212747American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597.
PubMed 17277604Lee EC, Fragala MS, Kavouras SA, Queen RM, Pryor JL, Casa DJ. Biomarkers in Sports and Exercise: Tracking Health, Performance, and Recovery in Athletes. J Strength Cond Res. 2017 Oct;31(10):2920-2937. doi: 10.1519/JSC.0000000000002122.
PubMed 28737585Kenefick RW. Drinking Strategies: Planned Drinking Versus Drinking to Thirst. Sports Med. 2018 Mar;48(Suppl 1):31-37. doi: 10.1007/s40279-017-0844-6.
PubMed 29368181Love TD, Baker DF, Healey P, Black KE. Measured and perceived indices of fluid balance in professional athletes. The use and impact of hydration assessment strategies. Eur J Sport Sci. 2018 Apr;18(3):349-356. doi: 10.1080/17461391.2017.1418910. Epub 2018 Jan 24.
PubMed 29364084Maughan RJ, Shirreffs SM. Development of hydration strategies to optimize performance for athletes in high-intensity sports and in sports with repeated intense efforts. Scand J Med Sci Sports. 2010 Oct;20 Suppl 2:59-69. doi: 10.1111/j.1600-0838.2010.01191.x.
PubMed 20840563Evans GH, James LJ, Shirreffs SM, Maughan RJ. Optimizing the restoration and maintenance of fluid balance after exercise-induced dehydration. J Appl Physiol (1985). 2017 Apr 1;122(4):945-951. doi: 10.1152/japplphysiol.00745.2016. Epub 2017 Jan 26.
PubMed 28126906Pence J, Bloomer RJ. Impact of Nuun Electrolyte Tablets on Fluid Balance in Active Men and Women. Nutrients. 2020 Oct 2;12(10):3030. doi: 10.3390/nu12103030.
PubMed 33023276Maughan RJ, Watson P, Cordery PA, Walsh NP, Oliver SJ, Dolci A, Rodriguez-Sanchez N, Galloway SD. A randomized trial to assess the potential of different beverages to affect hydration status: development of a beverage hydration index. Am J Clin Nutr. 2016 Mar;103(3):717-23. doi: 10.3945/ajcn.115.114769. Epub 2015 Dec 23.
PubMed 26702122
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Buoy on Hydration Status of Active Men and Women
- ClinicalTrials.gov ID
- NCT05768789
- Acronym / sponsor ID
- STUDY22090018
- Conditions
- Dehydration, Electrolyte Imbalance, Electrolyte Depletion, Fluid and Electrolyte Imbalance
- Keywords
- dehydration, electrolyte, electrolyte supplement, electrolyte loss, electrolyte ingestion, hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 27 Apr 2024 (actual)
- Study completion
- 27 Apr 2024 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Buoy is an all-natural, organic, FDA compliant dietary electrolyte supplement that can be dissolved in 8-12oz water (or other liquid) and provide electrolytes in servings of 1/3 teaspoon. This study will evaluate Buoy in hydrating active adults.
Detailed description
Prior to initiation of the study, participants will have a screening visit to complete informed consent and health history. The history for females will include their last date for menstruation and/or birth control method to take into consideration the effects of ovulation on water retention. During this visit we will measure heart rate, blood pressure, height, weight. Females will be administered a urine pregnancy test.
Participants must refrain from vigorous exercise within 24 hours of study visit. Participants will fast (food) overnight for 10h prior to initiation of test. Upon waking they are asked to empty their bowel \& bladder. They can consume one 8oz cup of coffee or other liquid. They will present at 7-8am at which time they will be asked to empty their bladder again. After resting for 5 minutes baseline vitals will be taken, including blood pressure, heart rate, weight, bioimpedance. Urinalysis dipstick for protein/blood/glucose and i-STAT measurement for creatinine and electrolytes on Visit 1 to confirm eligibility. For Visit 2 and Visit 3, the participant will be asked to review medical history and any change in status may warrant an additional baseline creatinine and blood/protein test to confirm eligibility. Additional food or beverage will not be allowed throughout the study period. All studies will be repeated in the same subject using either Buoy (intervention) or water (control) or Nuun (intervention). Urine will be collected at four specific timepoints during the intervention and the volume will be recorded. If participants need to urinate between scheduled collection times, urine will be collected, volume recorded, and combined with the urine collection of the following timepoint. These urine samples will be measured and a fraction of it will be sent to the lab to be tested for the following electrolytes: sodium, potassium, chloride and urine osmolarity. Urine creatinine will also be tested at these timepoints.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the interventions in the same order one after the other on different days (Buoy, then Water, then Nuun) to complete the 3 arms of the study
| Arm | Type | Receives |
|---|---|---|
| Buoy Electrolyte then Water only then Nuun Electrolyte | Experimental | Dietary Supplement: Buoy Electrolyte, Other: Water only, Dietary Supplement: Nuun ElectrolyteVisit 1: Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours. The goal is to give 600mg of Na+ over 4 hours while measuring urine output over 6 hours. Therefore, to safely achieve a total dose 600mg Na+ (6-fold increase from single dose) we will use 4 tsps (18 ml) of Buoy diluted in 1 L of water. Visit 2: Water serves as a control. Participants will ingest the same quantity of water (1 L) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours. Visit 3: Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight. The goal is to give a one-time dose of Nuun (600mg Na+) at the start of the trial, diluted in 1L water to be consumed within 30 min (similar to prior published data, Pence 2020). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female, >18 to 45 years of age
- Freely given written consent
- Non-tobacco users
- Negative pregnancy test in women of childbearing potential
- BMI < 35 kg/m2
Key exclusion criteria (8 listed)
- Abnormal creatinine (Cr > 1.2).
- Proteinuria / hematuria / glucosuria based on urine dipstick.
- Diagnosed medical condition that would impede results (CHF, HTN, CAD, CKD, history of electrolyte abnormality).
- Pregnancy
- Use of diuretics within past 2 weeks
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 |
|---|---|---|
| Buoy ElectrolyteEach subject consumed Beverage 1 (Buoy Hydration Drops) at a dose containing 600 mg/L of Na+ over 4 hours while measuring urine output over 6 hours. | Dietary supplement | Buoy Electrolyte then Water only then Nuun Electrolyte |
| Water onlyEach subjected ingested 1 L of Kirkland® bottled water at a rate of 6.25% of the total amount of water every 15 minutes for four hours | Other | Buoy Electrolyte then Water only then Nuun Electrolyte |
| Nuun ElectrolyteEach subject consumed 1 L of water with two dissolved Nuun® Sport Hydration tabs (Nuun, Seattle, WA), containing 600 mg of sodium, over 30 minutes (2 equal volumes every 15 minutes) while measuring urine output over 6 hours ( | Dietary supplement | Buoy Electrolyte then Water only then Nuun Electrolyte |
Primary outcome
Net Fluid Balance
Time frame: 360 minutes after ingestion
Determined by subtracting the cumulative urine output from the total fluid load consumed
Electrolytes in Urine
Time frame: Urine will be measured during each visit (three total visits that each last 6 hours)
Sodium levels will be measured
Urine Osmolarity (mOsm/kg)
Time frame: 360 minutes after ingestion
Osmolarity measures the concentration of solutes in urine. This is a key indicator of how concentrated or diluted the urine is, which directly reflects hydration status and kidney function. This can fluctuate depending on how much water the kidneys are excreting or retaining.
1 secondary outcome
Bio Impedance
Time frame: 360-minutes after ingestion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28614817Perrier ET. Shifting Focus: From Hydration for Performance to Hydration for Health. Ann Nutr Metab. 2017;70 Suppl 1:4-12. doi: 10.1159/000462996. Epub 2017 Jun 15.
- Background: PubMed 30609670Liska D, Mah E, Brisbois T, Barrios PL, Baker LB, Spriet LL. Narrative Review of Hydration and Selected Health Outcomes in the General Population. Nutrients. 2019 Jan 1;11(1):70. doi: 10.3390/nu11010070.
- Background: PubMed 20646222Popkin BM, D'Anci KE, Rosenberg IH. Water, hydration, and health. Nutr Rev. 2010 Aug;68(8):439-58. doi: 10.1111/j.1753-4887.2010.00304.x.
- Background: PubMed 28508338Nuccio RP, Barnes KA, Carter JM, Baker LB. Fluid Balance in Team Sport Athletes and the Effect of Hypohydration on Cognitive, Technical, and Physical Performance. Sports Med. 2017 Oct;47(10):1951-1982. doi: 10.1007/s40279-017-0738-7.
- Background: PubMed 15212747Von Duvillard SP, Braun WA, Markofski M, Beneke R, Leithauser R. Fluids and hydration in prolonged endurance performance. Nutrition. 2004 Jul-Aug;20(7-8):651-6. doi: 10.1016/j.nut.2004.04.011.
- Background: PubMed 17277604American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597.
- Background: PubMed 28737585Lee EC, Fragala MS, Kavouras SA, Queen RM, Pryor JL, Casa DJ. Biomarkers in Sports and Exercise: Tracking Health, Performance, and Recovery in Athletes. J Strength Cond Res. 2017 Oct;31(10):2920-2937. doi: 10.1519/JSC.0000000000002122.
- Background: PubMed 29368181Kenefick RW. Drinking Strategies: Planned Drinking Versus Drinking to Thirst. Sports Med. 2018 Mar;48(Suppl 1):31-37. doi: 10.1007/s40279-017-0844-6.
- Background: PubMed 29364084Love TD, Baker DF, Healey P, Black KE. Measured and perceived indices of fluid balance in professional athletes. The use and impact of hydration assessment strategies. Eur J Sport Sci. 2018 Apr;18(3):349-356. doi: 10.1080/17461391.2017.1418910. Epub 2018 Jan 24.
- Background: PubMed 20840563Maughan RJ, Shirreffs SM. Development of hydration strategies to optimize performance for athletes in high-intensity sports and in sports with repeated intense efforts. Scand J Med Sci Sports. 2010 Oct;20 Suppl 2:59-69. doi: 10.1111/j.1600-0838.2010.01191.x.
- Background: PubMed 28126906Evans GH, James LJ, Shirreffs SM, Maughan RJ. Optimizing the restoration and maintenance of fluid balance after exercise-induced dehydration. J Appl Physiol (1985). 2017 Apr 1;122(4):945-951. doi: 10.1152/japplphysiol.00745.2016. Epub 2017 Jan 26.
- Background: PubMed 33023276Pence J, Bloomer RJ. Impact of Nuun Electrolyte Tablets on Fluid Balance in Active Men and Women. Nutrients. 2020 Oct 2;12(10):3030. doi: 10.3390/nu12103030.
- 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.
Harikesh Subramanian, MBBS principal investigator
UPMC Department of Anesthesiology and Perioperative Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buoy Electrolyte, Water only and Nuun Electrolyte in people with Dehydration and Electrolyte Imbalance, run by University of Pittsburgh at 2 sites in United States.
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 12 inclusion and 8 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Net Fluid Balance (time frame: 360 minutes after ingestion). The study lists 3 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 NCT05768789, which also lists 13 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 14 May 2025.