Exercise-Induced FatigueGKK1-FatigueNCT06893549
Effect of Lactobacillus Plantarum GKK1 Supplementation on Anti-fatigue Health Effects
A study testing Lactobacillus plantarum GKK1 Probiotic in people with Exercise-Induced Fatigue and Muscle Fatigue, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
Title: Effect of Lactobacillus plantarum GKK1 Supplementation on Anti-Fatigue Health Effects: A Randomized, Double-Blind, Placebo-Controlled Trial This study aims to investigate the effects of Lactobacillus plantarum GKK1 supplementation on fatigue reduction and physical performance enhancement in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-Induced Fatigue, Muscle Fatigue, Sports Performance
- What is being tested?
- Lactobacillus plantarum GKK1 Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Sep 2024to 14 Mar 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 35 years
- Non-smokers and non-alcohol drinkers
- No history of chronic disease (e.g., cardiovascular disease, diabetes, asthma, metabolic disorders)
- No musculoskeletal injuries in the past 6 months
- Not taking anti-inflammatory or pain-relief medication in the past month
- No history of gastrointestinal surgery (excluding hernia or polyp removal)
- No allergies to dairy or probiotics
Who cannot join
- Diagnosed with cardiovascular, metabolic, or neurological disorders
- Regular consumption of probiotics within the last three months
- Pregnant or lactating women
- Individuals taking medication affecting hormonal balance or immune response
- Use of corticosteroids, NSAIDs, or muscle relaxants in the past month
- Participating in another clinical trial within the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Title: Effect of Lactobacillus plantarum GKK1 Supplementation on Anti-Fatigue Health Effects: A Randomized, Double-Blind, Placebo-Controlled Trial
This study aims to investigate the effects of Lactobacillus plantarum GKK1 supplementation on fatigue reduction and physical performance enhancement in healthy adults. Probiotics are known to modulate gut microbiota and may influence exercise-induced fatigue and recovery.
Read more
A total of 48 healthy adults aged 18-35 years will be randomly assigned to either the probiotic group (Lactobacillus plantarum GKK1, 100 billion CFU/day) or the placebo group, with supplementation for 28 consecutive days. On Day 29, participants will perform an exhaustive exercise test, and their anaerobic power, explosive power, isometric muscle strength, and stress hormone levels (cortisol, catecholamines, GH, testosterone, hs-CRP) will be evaluated before and after exercise.
The primary objective is to assess whether probiotic supplementation can reduce exercise-induced fatigue and muscle damage while improving recovery performance. Blood biochemical markers, muscle damage indicators, and subjective fatigue perception will also be analyzed.
This study is conducted at National Taiwan Sport University, under ethical approval from Landseed Hospital IRB (IRB-24-034-A2).
Read the detailed description
Probiotic supplementation has garnered increasing interest in sports science due to its potential effects on gut microbiota modulation, systemic inflammation, and exercise recovery. Lactobacillus plantarum GKK1, a strain isolated from fermented plant sources, exhibits promising antioxidative and anti-inflammatory properties, making it a candidate for supporting physical resilience and fatigue recovery in active individuals.
This study is designed as a randomized, double-blind, placebo-controlled clinical trial aiming to evaluate whether supplementation with L. plantarum GKK1 can attenuate physiological stress responses and muscle damage following exhaustive exercise in healthy adults. The probiotic intervention lasts for 28 consecutive days, during which participants maintain habitual dietary and lifestyle behaviors, except for the avoidance of other functional supplements.
The experimental exercise model includes a structured fatigue-inducing protocol involving repetitive plyometric movements. This model was selected to simulate high-intensity sport-like conditions while reliably inducing measurable muscle stress. Following this challenge, blood and urine samples are collected at predefined time points to monitor temporal changes in selected biochemical markers.
The trial incorporates both objective and subjective metrics, including validated physical performance tests and standardized fatigue perception scales. Biochemical assessments are conducted using automated clinical analyzers and immunoassay techniques under Good Laboratory Practice conditions. The core hypothesis posits that probiotic intervention will result in lower elevations in stress hormones and muscle damage biomarkers, along with improved physical performance maintenance compared to placebo.
All procedures are conducted at the National Taiwan Sport University under IRB approval (IRB-24-034-A2). This trial may provide evidence for the application of probiotic supplementation as a supportive strategy for fatigue management and exercise recovery enhancement in recreationally active populations.
- Being tested
- Lactobacillus plantarum GKK1 Probiotic, Placebo
- Keywords
- Probiotic Supplement, Exercise Fatigue, Lactiplantibacillus paraplantarum GKK1, Physical Performance, Muscle Damage, Recovery, Anaerobic Power, Explosive Power, Isometric Strength, Sports Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum GKK1 ProbioticDietary supplement
Also called Probiotic Supplement
Participants in the probiotic group will receive a daily oral supplementation of Lactobacillus plantarum GKK1 probiotic capsules for 28 days. Each capsule contains 50 billion CFU, with a total daily intake of 100 billion CFU. The probiotic strain Lactobacillus plantarum GKK1 has been selected for its potential benefits in reducing exercise-induced fatigue and enhancing physical performance. The supplementation period will be followed by an exhaustive exercise test to assess physiological and biochemical changes.
PlaceboDietary supplement
Also called Placebo Supplement
Participants in the placebo group will receive a daily oral supplementation of placebo capsules for 28 days. The placebo capsules are identical in appearance, taste, and weight to the probiotic capsules but contain only microcrystalline α-cellulose, magnesium stearate, and silicon dioxide. The supplementation period will be followed by an exhaustive exercise test to assess physiological and biochemical changes.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum GKK1 Probiotic Group | Experimental | Participants in this group will receive a daily oral supplementation of Lactobacillus plantarum GKK1 probiotic capsules for 28 days. Each capsule contains 50 billion CFU, with a total daily intake of 100 billion CFU. On Day 29, participants will undergo an exhaustive exercise test, and various physiological and biochemical markers will be assessed pre- and post-exercise. Receives: Dietary Supplement: Lactobacillus plantarum GKK1 Probiotic |
| Placebo Group | Placebo comparator | Participants in this group will receive a daily oral supplementation of placebo capsules for 28 days. The placebo capsules contain microcrystalline α-cellulose, magnesium stearate, and silicon dioxide, with identical appearance and taste to the probiotic capsules. On Day 29, participants will undergo an exhaustive exercise test, and various physiological and biochemical markers will be assessed pre- and post-exercise. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anaerobic Power
Anaerobic power will be assessed using a Wingate anaerobic test. Measurements include peak power (W/kg), average power (W/kg), and fatigue index (%). Higher values indicate better performance and lower fatigue.
Measured: Time Frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Secondary outcomes (7)
Change in Cortisol Levels
Serum cortisol levels (nmol/L) will be measured using enzyme-linked immunosorbent assay (ELISA). Cortisol is a biomarker of physiological stress and fatigue. Changes in cortisol concentration will be used to assess the participant's stress response to exhaustive exercise.
Measured: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Catecholamines Levels
Serum catecholamines (epinephrine, norepinephrine, and dopamine) will be measured using high-performance liquid chromatography (HPLC). These biomarkers reflect sympathetic nervous system activity and are associated with exercise-induced stress and fatigue.
Measured: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in hs-CRP Levels
High-sensitivity C-reactive protein (hs-CRP) will be measured in serum (mg/L) using ELISA. hs-CRP is a marker of systemic inflammation and may increase in response to intense physical stress. This measurement helps assess the anti-inflammatory effect of probiotic supplementation.
Measured: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Creatine Kinase (CK)
Serum creatine kinase (CK) activity (U/L) will be assessed using an automated biochemical analyzer. CK is a widely used marker of muscle damage following intense exercise. Elevated levels may indicate muscle cell injury.
Measured: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Myoglobin Levels
Serum myoglobin (ng/mL) will be measured using a commercial assay kit. Myoglobin is released into the blood following muscle damage and is used as an early indicator of exercise-induced muscle injury.
Measured: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in 3-Methylhistidine Levels
Urinary 3-methylhistidine concentration will be measured as a biomarker of muscle protein breakdown. The ratio of 3-methylhistidine to creatinine (μmol/mmol) will be used to assess muscle catabolism post-exercise.
Measured: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Subjective Fatigue Perception Score
Subjective fatigue perception will be assessed using a 10-point visual analog scale, where 0 indicates no fatigue and 10 indicates extreme fatigue. Participants will rate their perceived fatigue at specified time points to evaluate recovery.
Measured: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start24 Sep 2024
- Primary completion1 Nov 2024
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exercise-Induced FatigueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, double-blind, placebo-controlled parallel-group trial comparing the effects of Lactobacillus plantarum GKK1 supplementation with a placebo in healthy adults.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Principal investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893549
- Sponsor's protocol ID
- IRB-24-034-A2
- Other IDs
- IRB-24-034-A2
- Acronym
- GKK1-Fatigue
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee MC, Hsu YJ, Ho CS, Chang CH, Liu CW, Huang CC, Chiang WD. Evaluation of the Efficacy of Supplementation with Planox(R) Lemon Verbena Extract in Improving Oxidative Stress and Muscle Damage: A Randomized Double-Blind Controlled Trial. Int J Med Sci. 2021 May 3;18(12):2641-2652. doi: 10.7150/ijms.60726. eCollection 2021.
PubMed 34104096Lee MC, Chen CY, Shih YT, Tsai YS, Lin SW, Chen YL, Chen CC, Huang CC. Effect of Lactiplantibacillus plantarum GKK1 Supplementation on Exercise-Induced Fatigue, Muscle Damage, and Recovery in Healthy Men: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2026 Aug 25;18(17):2782. doi: 10.3390/nu18172782.
PubMed 42738954
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactobacillus Plantarum GKK1 Supplementation on Anti-fatigue Health Effects
- ClinicalTrials.gov ID
- NCT06893549
- Acronym / sponsor ID
- GKK1-Fatigue / IRB-24-034-A2
- Keywords
- Probiotic Supplement, Exercise Fatigue, Lactiplantibacillus paraplantarum GKK1, Physical Performance, Muscle Damage, Recovery, Anaerobic Power, Explosive Power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 25 Mar 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.
Title: Effect of Lactobacillus plantarum GKK1 Supplementation on Anti-Fatigue Health Effects: A Randomized, Double-Blind, Placebo-Controlled Trial
This study aims to investigate the effects of Lactobacillus plantarum GKK1 supplementation on fatigue reduction and physical performance enhancement in healthy adults. Probiotics are known to modulate gut microbiota and may influence exercise-induced fatigue and recovery.
A total of 48 healthy adults aged 18-35 years will be randomly assigned to either the probiotic group (Lactobacillus plantarum GKK1, 100 billion CFU/day) or the placebo group, with supplementation for 28 consecutive days. On Day 29, participants will perform an exhaustive exercise test, and their anaerobic power, explosive power, isometric muscle strength, and stress hormone levels (cortisol, catecholamines, GH, testosterone, hs-CRP) will be evaluated before and after exercise.
The primary objective is to assess whether probiotic supplementation can reduce exercise-induced fatigue and muscle damage while improving recovery performance. Blood biochemical markers, muscle damage indicators, and subjective fatigue perception will also be analyzed.
This study is conducted at National Taiwan Sport University, under ethical approval from Landseed Hospital IRB (IRB-24-034-A2).
Detailed description
Probiotic supplementation has garnered increasing interest in sports science due to its potential effects on gut microbiota modulation, systemic inflammation, and exercise recovery. Lactobacillus plantarum GKK1, a strain isolated from fermented plant sources, exhibits promising antioxidative and anti-inflammatory properties, making it a candidate for supporting physical resilience and fatigue recovery in active individuals.
This study is designed as a randomized, double-blind, placebo-controlled clinical trial aiming to evaluate whether supplementation with L. plantarum GKK1 can attenuate physiological stress responses and muscle damage following exhaustive exercise in healthy adults. The probiotic intervention lasts for 28 consecutive days, during which participants maintain habitual dietary and lifestyle behaviors, except for the avoidance of other functional supplements.
The experimental exercise model includes a structured fatigue-inducing protocol involving repetitive plyometric movements. This model was selected to simulate high-intensity sport-like conditions while reliably inducing measurable muscle stress. Following this challenge, blood and urine samples are collected at predefined time points to monitor temporal changes in selected biochemical markers.
The trial incorporates both objective and subjective metrics, including validated physical performance tests and standardized fatigue perception scales. Biochemical assessments are conducted using automated clinical analyzers and immunoassay techniques under Good Laboratory Practice conditions. The core hypothesis posits that probiotic intervention will result in lower elevations in stress hormones and muscle damage biomarkers, along with improved physical performance maintenance compared to placebo.
All procedures are conducted at the National Taiwan Sport University under IRB approval (IRB-24-034-A2). This trial may provide evidence for the application of probiotic supplementation as a supportive strategy for fatigue management and exercise recovery enhancement in recreationally active populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, double-blind, placebo-controlled parallel-group trial comparing the effects of Lactobacillus plantarum GKK1 supplementation with a placebo in healthy adults.
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum GKK1 Probiotic Group | Experimental | Dietary Supplement: Lactobacillus plantarum GKK1 ProbioticParticipants in this group will receive a daily oral supplementation of Lactobacillus plantarum GKK1 probiotic capsules for 28 days. Each capsule contains 50 billion CFU, with a total daily intake of 100 billion CFU. On Day 29, participants will undergo an exhaustive exercise test, and various physiological and biochemical markers will be assessed pre- and post-exercise. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group will receive a daily oral supplementation of placebo capsules for 28 days. The placebo capsules contain microcrystalline α-cellulose, magnesium stearate, and silicon dioxide, with identical appearance and taste to the probiotic capsules. On Day 29, participants will undergo an exhaustive exercise test, and various physiological and biochemical markers will be assessed pre- and post-exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged 18 to 35 years
- Non-smokers and non-alcohol drinkers
- No history of chronic disease (e.g., cardiovascular disease, diabetes, asthma, metabolic disorders)
- No musculoskeletal injuries in the past 6 months
- Not taking anti-inflammatory or pain-relief medication in the past month
Key exclusion criteria (6 listed)
- Diagnosed with cardiovascular, metabolic, or neurological disorders
- Regular consumption of probiotics within the last three months
- Pregnant or lactating women
- Individuals taking medication affecting hormonal balance or immune response
- Use of corticosteroids, NSAIDs, or muscle relaxants in the past month
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 |
|---|---|---|
| Lactobacillus plantarum GKK1 ProbioticAlso: Probiotic SupplementParticipants in the probiotic group will receive a daily oral supplementation of Lactobacillus plantarum GKK1 probiotic capsules for 28 days. Each capsule contains 50 billion CFU, with a total daily intake of 100 billion CFU. The probiotic strain Lactobacillus plantarum GKK1 has been selected for its potential benefits in reducing exercise-induced fatigue and enhancing physical performance. The supplementation period will be followed by an exhaustive exercise test to assess physiological and biochemical changes. | Dietary supplement | Lactobacillus plantarum GKK1 Probiotic Group |
| PlaceboAlso: Placebo SupplementParticipants in the placebo group will receive a daily oral supplementation of placebo capsules for 28 days. The placebo capsules are identical in appearance, taste, and weight to the probiotic capsules but contain only microcrystalline α-cellulose, magnesium stearate, and silicon dioxide. The supplementation period will be followed by an exhaustive exercise test to assess physiological and biochemical changes. | Dietary supplement | Placebo Group |
Primary outcome
Change in Anaerobic Power
Time frame: Time Frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Anaerobic power will be assessed using a Wingate anaerobic test. Measurements include peak power (W/kg), average power (W/kg), and fatigue index (%). Higher values indicate better performance and lower fatigue.
7 secondary outcomes
Change in Cortisol Levels
Time frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Catecholamines Levels
Time frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in hs-CRP Levels
Time frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Creatine Kinase (CK)
Time frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Myoglobin Levels
Time frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in 3-Methylhistidine Levels
Time frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Change in Subjective Fatigue Perception Score
Time frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
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 26 Mar 2025.
- Results publication: PubMed 34104096Lee MC, Hsu YJ, Ho CS, Chang CH, Liu CW, Huang CC, Chiang WD. Evaluation of the Efficacy of Supplementation with Planox(R) Lemon Verbena Extract in Improving Oxidative Stress and Muscle Damage: A Randomized Double-Blind Controlled Trial. Int J Med Sci. 2021 May 3;18(12):2641-2652. doi: 10.7150/ijms.60726. eCollection 2021.
- Derived from this study: PubMed 42738954Lee MC, Chen CY, Shih YT, Tsai YS, Lin SW, Chen YL, Chen CC, Huang CC. Effect of Lactiplantibacillus plantarum GKK1 Supplementation on Exercise-Induced Fatigue, Muscle Damage, and Recovery in Healthy Men: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2026 Aug 25;18(17):2782. doi: 10.3390/nu18172782.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum GKK1 Probiotic in people with Exercise-Induced Fatigue and Muscle Fatigue, run by National Taiwan Sport University at 1 site in Taiwan.
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 7 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 26 Mar 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 Taiwan. 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?
Change in Anaerobic Power (time frame: Time Frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise). 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 NCT06893549, which also lists 2 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 26 Mar 2025.