Physical ExercisePTS2025NCT06969898
Penyagolosa Trail Saludable 2025
An observational study of Physical Exercise, run by Universitat Jaume I at 1 site in Spain.
Trial summary
The research team leading this project frames it within the objective of advancing knowledge about what happens to this group of athletes who participate in Ultratrail events, with the particularity of studying them during the race itself. To achieve this, the study aims to address four key perspectives. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exercise
- What is being tested?
- Single Ultramarathon runners
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 31 Jul 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Ultra-trail runners that will participate in the CSP2025 race (Castellón, Spain; 2025/04/11-12)
Who may be able to join
- Adults healthy with 18-60 years
- Must have completed at least two races of 65 km or longer.
- Must be registered as a participant in the CSP 2025 race
Who cannot join
- Having heart disease
- Having kidney disease
- Taking a medication on an ongoing basis
Trial locations and contacts
1 site in 1 country.
About this study
The research team leading this project frames it within the objective of advancing knowledge about what happens to this group of athletes who participate in Ultratrail events, with the particularity of studying them during the race itself. To achieve this, the study aims to address four key perspectives.
First, it seeks to understand the training habits of male and female Ultratrail runners. Second, it aims to assess their physical condition and analyze how uphill and downhill segments affect their muscle performance, running efficiency, and strength levels. Third, it investigates the key factors that determine the prediction of race performance for both male and female runners. Finally, the fourth objective is to examine sex differences as a conditioning factor in physiological processes.
Read the detailed description
There is a category of sporting events held in natural environments over very long distances, classified as Ultratrail races. These races have grown in popularity, attracting an increasing number of participants.
Such races induce states of exhaustion and fatigue, with performance being influenced by numerous factors (environmental conditions, terrain, course profile, etc.), in addition to the athlete's individual characteristics. Scientific interest in these events has surged, and the research community is closely monitoring the health status of participants and their involvement in such races. The aim is to identify the factors influencing performance in a 106 km race (Castelló-Penyagolosa of Penyagolosa Trails) and to assess the physiological impact of participating in this type of endurance event.
To conduct this study, data collection took place before the race, during the race, and within the 48-hour post-race recovery phase.
Before the race, two laboratory sessions were conducted to analyze the athlete's physical condition and assess muscle damage under conditions of both uphill and downhill running. Blood samples were taken before and after these tests.
On race day, measurements included strength loss, weight, dehydration levels, race nutrition, and the evolution of physiological parameters through blood and urine analyses conducted before and after the race.
Finally, blood samples were collected at 24-hours and 48-hours post-race to track the progression of physiological parameters during the recovery phase.
- Conditions
- Physical Exercise
- Being tested
- Single Ultramarathon runners
- Keywords
- Ultramarathon, biomarkers, Muscle damage, recovery, runners, ultrasound
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Ultramarathon runnersOther
All participants underwent the same protocol: two laboratory assessments, a 106 km race, and post-race physiological parameter evaluations at 24 hours and 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Single Ultramarathon runners | All participants underwent the same protocol: two laboratory assessments, a 106 km race, and post-race physiological parameter evaluations at 24 hours and 48 hours. Receives: Other: Single Ultramarathon runners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Parameters
Blood Analysis: Blood samples will be analyzed for the following parameters:
- Number of red cells in a volume of blood in µL. (number of red cells x10^6 / µL )
- Creatine Kinase (CK) in International Units in a volume of blood in litres. (U/L)
- Lactate Dehydrogenase (LDH) in International Units in a volume of blood in litres. (U/L)
- C-reactive Protein (CRP) in milligrams in a volume of blood in litres. (mg/L)
- Sodium (Na) in millimoles in a volume of blood in litres (mmol/L)
- Potassium (K) in millimoles in a volume of blood in litres (mmol/L)
- Interleukin 6 (IL-6) in picograms in a volume of blood (pg/dL)
Blood Sample Collection: Blood samples will be collected twice during the second laboratory session-once before starting the treadmill test (negative 15% incline for 5 km at VT1 speed) and again 30 minutes after completing the test. Additional blood samples will be taken at baseline before the race, at the finish line, 24 hours post-race, and 48 hours post-race.
Measured: From the enrollment to 48 hours post-race (12 weeks). Baseline (4 weeks after enrollment), post-1-2-3 and 4, 11th week (11 weeks after baseline)
Muscle Damage
The knee extensors will be measured using ultrasound. Muscle fibre thickness of Rectus femoris and Vastus lateralis will be measured in cm.
Pennation angle of muscle fibre of Rectus femoris and Vastus lateralis will be measured in degrees.
The ankle extensors will be measured using ultrasound. Muscle fibre thickness of Medial gastrocnemius will be measured in cm. Pennation angle of muscle fibre of Medial gastrocnemius will be measured in degrees.
Assessments will be conducted twice during the second laboratory session: once before starting the treadmill test (-15% incline for 5 km at VT1 speed) and again 30 minutes after completing the test. Additionally, measurements will be taken at baseline before the race start and at the finish line
Measured: From the enrolment to 48 hours post-race (12 weeks). First measured of knee and ankle extensors will be in 5th week (4 weeks after baseline). Second, and third measured of knee and ankle extensors will be in 11th week (10 weeks after baseline).
Strength levels
Measurements:
- Squat Jump (SJ): Jump height in centimetres will be measured during a vertical jump performed from a squat position without a countermovement.
- Reactive Strength Index (RSI): The subject performs a sequence of 10 consecutive jumps, during which flight time (in milliseconds) and ground contact time (in milliseconds) are measured. These two variables are used to calculate the Reactive Strength Index (RSI), defined as the ratio of flight time to contact time (flight time in milliseconds / contact time in milliseconds).
- Maximal Isometric Strength (MIS): The isometric strength of the knee and ankle extensors will be measured in Newtons (N).
Collection of Measurements: • Squat Jump will be evaluated during the first laboratory session (first week), before and after cardiopulmonary test (two jumps per attempt). • Reactive Jump will be assessed during the first laboratory session (first week), before and after the 5 km at VT1 speed treadmill test (-15% incline)
Measured: First SJ measured (first week), second SJ at day before the race (11th week) third SJ at the end of the race (11th week). RSI will be measured at the first laboratory session (1st week). MIS will be measured at the second laboratory session (5th week)
Physical activity data
Accelerometry:
Physical activity (counts per minute, CPM) will be measured using an accelerometer placed on the non-dominant wrist. Activity levels will be classified into six categories: sedentary, light, moderate, vigorous, very vigorous, and extremely vigorous.
Collection of Measurements:
- Accelerometry will be recorded during laboratory assessments.
- An accelerometer will be placed on the participant the day before the race to continuously collect physical activity data until 48 hours post-race.
Measured: Laboratory 4 weeks before the race. During the race 96 hours (from the day before the race to 48hours post-race)
Physiological Parameters
Urine Samples:
Urinary density (mg/dL)
Urine samples will be collected at baseline before the race and at the finish line, with measurements of urinary density (Units: mg/dL).
Measured: At the start line of the race (11th week) and at the end of the race (11th week)
Secondary outcomes (5)
Body Composition & Anthropometry
Weight in kilograms, height in meters. Weight and height will be combined to report BMI in kg/m^2.
Assessed using bioelectrical impedance analysis (BIA) to estimate percentage of fat mass (%), percentage of fat-free mass (%), and total body water (L). The percentage of fat mass (%), percentage of fat-free mass (%), and total body water (L) will be used to know the body composition of the subject combining the percentage of fat mass, percentage of fat free mass and total body water.
Collection of Measurements:
- Weight, height, BMI, percentage of fat mass, percentage of fat-free mass, total body water and Body composition will be measured during the first laboratory assessment (1st week)
Measured: Baseline (1st week)
Physical Condition
Maximal Oxygen Consumption (V ̇O2max):
Number of millilitres of oxygen consumption, weight in kilograms and time in minutes will be combined to calculated the Maximal Oxygen Consumption. Millilitres per kilogram per minute (mL/kg/min).
Oxidation Substrate Levels: Assessed through indirect calorimetry to determine number of carbohydrate grams and number of fat grams oxidation rates per minute (g/min).
Collection of Measurements:
- V ̇O2max will be evaluated in baseline laboratory assessment (1st week).
- Oxidation substrate levels will be measured during the second laboratory assessment (5th week).
Measured: Baseline (1st week) and post baseline (5th week)
Muscle Oxygenation Measurement
Oxygen Saturation Levels: Measured in the muscles involved in running using near-infrared spectroscopy (NIRS) and expressed as a percentage (%).
Collection of Measurements: Oxygen saturation levels will be assessed during two laboratory tests.
Measured: Baseline (Day 1) and post baseline (4 weeks after baseline)
Running Power Measurement
Power Output: Measured in watts (W) using a power meter to assess mechanical performance during running.
Collection of Measurements: Power output will be recorded during the two treadmill tests conducted in the laboratory.
Measured: Baseline (Day 1) and post baseline (4 weeks after baseline)
Weight
Body mass (kg)
Weight is measured in kilograms at the starting line, at three race checkpoints (32 km, 62 km, and 81 km), and at the finish line.
Measured: The start line of the race (11th week), during the intervention three times during the race (in km 32, in km 62 and in km 81) and at the end of the race (11th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jan 2025
- Primary completion31 Mar 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical ExerciseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Hernando, Principal investigator, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969898
- Sponsor's protocol ID
- PTS2025 CEISH/103/2024
- Acronym
- PTS2025
- Status last verified
- Oct 2025
- First submitted
- 17 Mar 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hernando C, Hernando C, Collado EJ, Panizo N, Martinez-Navarro I, Hernando B. Establishing cut-points for physical activity classification using triaxial accelerometer in middle-aged recreational marathoners. PLoS One. 2018 Aug 29;13(8):e0202815. doi: 10.1371/journal.pone.0202815. eCollection 2018.
PubMed 30157271Guerrero C, Collado-Boira E, Martinez-Navarro I, Hernando B, Hernando C, Balino P, Muriach M. Impact of Plasma Oxidative Stress Markers on Post-race Recovery in Ultramarathon Runners: A Sex and Age Perspective Overview. Antioxidants (Basel). 2021 Feb 27;10(3):355. doi: 10.3390/antiox10030355.
PubMed 33673404Granero-Gallegos A, Gonzalez-Quilez A, Plews D, Carrasco-Poyatos M. HRV-Based Training for Improving VO2max in Endurance Athletes. A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2020 Oct 30;17(21):7999. doi: 10.3390/ijerph17217999.
PubMed 33143175Baygutalp F, Buzdagli Y, Ozan M, Koz M, Kilic Baygutalp N, Atasever G. Impacts of different intensities of exercise on inflammation and hypoxia markers in low altitude. BMC Sports Sci Med Rehabil. 2021 Nov 22;13(1):145. doi: 10.1186/s13102-021-00375-0.
PubMed 34809670Baird MF, Graham SM, Baker JS, Bickerstaff GF. Creatine-kinase- and exercise-related muscle damage implications for muscle performance and recovery. J Nutr Metab. 2012;2012:960363. doi: 10.1155/2012/960363. Epub 2012 Jan 11.
PubMed 22288008
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penyagolosa Trail Saludable 2025
- ClinicalTrials.gov ID
- NCT06969898
- Acronym / sponsor ID
- PTS2025 / PTS2025 CEISH/103/2024
- Conditions
- Physical Exercise
- Keywords
- Ultramarathon, biomarkers, Muscle damage, recovery, runners, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 14 May 2025 (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.
The research team leading this project frames it within the objective of advancing knowledge about what happens to this group of athletes who participate in Ultratrail events, with the particularity of studying them during the race itself. To achieve this, the study aims to address four key perspectives.
First, it seeks to understand the training habits of male and female Ultratrail runners. Second, it aims to assess their physical condition and analyze how uphill and downhill segments affect their muscle performance, running efficiency, and strength levels. Third, it investigates the key factors that determine the prediction of race performance for both male and female runners. Finally, the fourth objective is to examine sex differences as a conditioning factor in physiological processes.
Detailed description
There is a category of sporting events held in natural environments over very long distances, classified as Ultratrail races. These races have grown in popularity, attracting an increasing number of participants.
Such races induce states of exhaustion and fatigue, with performance being influenced by numerous factors (environmental conditions, terrain, course profile, etc.), in addition to the athlete's individual characteristics. Scientific interest in these events has surged, and the research community is closely monitoring the health status of participants and their involvement in such races. The aim is to identify the factors influencing performance in a 106 km race (Castelló-Penyagolosa of Penyagolosa Trails) and to assess the physiological impact of participating in this type of endurance event.
To conduct this study, data collection took place before the race, during the race, and within the 48-hour post-race recovery phase.
Before the race, two laboratory sessions were conducted to analyze the athlete's physical condition and assess muscle damage under conditions of both uphill and downhill running. Blood samples were taken before and after these tests.
On race day, measurements included strength loss, weight, dehydration levels, race nutrition, and the evolution of physiological parameters through blood and urine analyses conducted before and after the race.
Finally, blood samples were collected at 24-hours and 48-hours post-race to track the progression of physiological parameters during the recovery phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Ultramarathon runners | – | Other: Single Ultramarathon runnersAll participants underwent the same protocol: two laboratory assessments, a 106 km race, and post-race physiological parameter evaluations at 24 hours and 48 hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Ultra-trail runners that will participate in the CSP2025 race (Castellón, Spain; 2025/04/11-12)
Key inclusion criteria (3 listed)
- Adults healthy with 18-60 years
- Must have completed at least two races of 65 km or longer.
- Must be registered as a participant in the CSP 2025 race
Key exclusion criteria (3 listed)
- Having heart disease
- Having kidney disease
- Taking a medication on an ongoing basis
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 |
|---|---|---|
| Single Ultramarathon runnersAll participants underwent the same protocol: two laboratory assessments, a 106 km race, and post-race physiological parameter evaluations at 24 hours and 48 hours. | Other | Single Ultramarathon runners |
Primary outcome
Physiological Parameters
Time frame: From the enrollment to 48 hours post-race (12 weeks). Baseline (4 weeks after enrollment), post-1-2-3 and 4, 11th week (11 weeks after baseline)
Blood Analysis: Blood samples will be analyzed for the following parameters: * Number of red cells in a volume of blood in µL. (number of red cells x10^6 / µL ) * Creatine Kinase (CK) in International Units in a volume of blood in litres. (U/L) * Lactate Dehydrogenase (LDH) in International Units in a volume of blood in litres. (U/L) * C-reactive Protein (CRP) in milligrams in a volume of blood in litres. (mg/L) * Sodium (Na) in millimoles in a volume of blood in litres (mmol/L) * Potassium (K) in millimoles in a volume of blood in litres (mmol/L) * Interleukin 6 (IL-6) in picograms in a volume of blood (pg/dL) Blood Sample Collection: Blood samples will be collected twice during the second laboratory session-once before starting the treadmill test (negative 15% incline for 5 km at VT1 speed) and again 30 minutes after completing the test. Additional blood samples will be taken at baseline before the race, at the finish line, 24 hours post-race, and 48 hours post-race.
Muscle Damage
Time frame: From the enrolment to 48 hours post-race (12 weeks). First measured of knee and ankle extensors will be in 5th week (4 weeks after baseline). Second, and third measured of knee and ankle extensors will be in 11th week (10 weeks after baseline).
The knee extensors will be measured using ultrasound. Muscle fibre thickness of Rectus femoris and Vastus lateralis will be measured in cm. Pennation angle of muscle fibre of Rectus femoris and Vastus lateralis will be measured in degrees. The ankle extensors will be measured using ultrasound. Muscle fibre thickness of Medial gastrocnemius will be measured in cm. Pennation angle of muscle fibre of Medial gastrocnemius will be measured in degrees. Assessments will be conducted twice during the second laboratory session: once before starting the treadmill test (-15% incline for 5 km at VT1 speed) and again 30 minutes after completing the test. Additionally, measurements will be taken at baseline before the race start and at the finish line
Strength levels
Time frame: First SJ measured (first week), second SJ at day before the race (11th week) third SJ at the end of the race (11th week). RSI will be measured at the first laboratory session (1st week). MIS will be measured at the second laboratory session (5th week)
Measurements: * Squat Jump (SJ): Jump height in centimetres will be measured during a vertical jump performed from a squat position without a countermovement. * Reactive Strength Index (RSI): The subject performs a sequence of 10 consecutive jumps, during which flight time (in milliseconds) and ground contact time (in milliseconds) are measured. These two variables are used to calculate the Reactive Strength Index (RSI), defined as the ratio of flight time to contact time (flight time in milliseconds / contact time in milliseconds). * Maximal Isometric Strength (MIS): The isometric strength of the knee and ankle extensors will be measured in Newtons (N). Collection of Measurements: • Squat Jump will be evaluated during the first laboratory session (first week), before and after cardiopulmonary test (two jumps per attempt). • Reactive Jump will be assessed during the first laboratory session (first week), before and after the 5 km at VT1 speed treadmill test (-15% incline)
Physical activity data
Time frame: Laboratory 4 weeks before the race. During the race 96 hours (from the day before the race to 48hours post-race)
Accelerometry: Physical activity (counts per minute, CPM) will be measured using an accelerometer placed on the non-dominant wrist. Activity levels will be classified into six categories: sedentary, light, moderate, vigorous, very vigorous, and extremely vigorous. Collection of Measurements: * Accelerometry will be recorded during laboratory assessments. * An accelerometer will be placed on the participant the day before the race to continuously collect physical activity data until 48 hours post-race.
Physiological Parameters
Time frame: At the start line of the race (11th week) and at the end of the race (11th week)
Urine Samples: Urinary density (mg/dL) Urine samples will be collected at baseline before the race and at the finish line, with measurements of urinary density (Units: mg/dL).
5 secondary outcomes
Body Composition & Anthropometry
Time frame: Baseline (1st week)
Physical Condition
Time frame: Baseline (1st week) and post baseline (5th week)
Muscle Oxygenation Measurement
Time frame: Baseline (Day 1) and post baseline (4 weeks after baseline)
Running Power Measurement
Time frame: Baseline (Day 1) and post baseline (4 weeks after baseline)
Weight
Time frame: The start line of the race (11th week), during the intervention three times during the race (in km 32, in km 62 and in km 81) and at the end of the race (11th week)
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 8 Oct 2025.
- Background: PubMed 30157271Hernando C, Hernando C, Collado EJ, Panizo N, Martinez-Navarro I, Hernando B. Establishing cut-points for physical activity classification using triaxial accelerometer in middle-aged recreational marathoners. PLoS One. 2018 Aug 29;13(8):e0202815. doi: 10.1371/journal.pone.0202815. eCollection 2018.
- Background: PubMed 33673404Guerrero C, Collado-Boira E, Martinez-Navarro I, Hernando B, Hernando C, Balino P, Muriach M. Impact of Plasma Oxidative Stress Markers on Post-race Recovery in Ultramarathon Runners: A Sex and Age Perspective Overview. Antioxidants (Basel). 2021 Feb 27;10(3):355. doi: 10.3390/antiox10030355.
- Background: PubMed 33143175Granero-Gallegos A, Gonzalez-Quilez A, Plews D, Carrasco-Poyatos M. HRV-Based Training for Improving VO2max in Endurance Athletes. A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2020 Oct 30;17(21):7999. doi: 10.3390/ijerph17217999.
- Background: PubMed 34809670Baygutalp F, Buzdagli Y, Ozan M, Koz M, Kilic Baygutalp N, Atasever G. Impacts of different intensities of exercise on inflammation and hypoxia markers in low altitude. BMC Sports Sci Med Rehabil. 2021 Nov 22;13(1):145. doi: 10.1186/s13102-021-00375-0.
- Background: PubMed 22288008Baird MF, Graham SM, Baker JS, Bickerstaff GF. Creatine-kinase- and exercise-related muscle damage implications for muscle performance and recovery. J Nutr Metab. 2012;2012:960363. doi: 10.1155/2012/960363. Epub 2012 Jan 11.
- Position-Statement-Supplements-and-Sports-FoodsLink provided by the sponsor.
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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.
Carlos Hernando principal investigator
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Exercise, run by Universitat Jaume I 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 3 inclusion and 3 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 8 Oct 2025. 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. 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?
Physiological Parameters (time frame: From the enrollment to 48 hours post-race (12 weeks). Baseline (4 weeks after enrollment), post-1-2-3 and 4, 11th week (11 weeks after baseline)). The study lists 5 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 NCT06969898, which also lists 5 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 8 Oct 2025; AzTrials last refreshed its copy on 2 Nov 2026.