Exercise-induced Muscle DamageNCT07836634
Effects of Nattokinase Supplementation on Strength Recovery and Muscle Damage Biomarkers Following Exercise-Induced Muscle Injury: A Pilot Study
A study testing Nattokinase in people with Exercise-induced Muscle Damage, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
This pilot study aims to investigate whether 4 weeks of nattokinase supplementation (2,000 FU/day) affects recovery following exercise-induced muscle damage in healthy adult men. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Muscle Damage
- What is being tested?
- Nattokinase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Sep 2026to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants aged 18 to 40 years.
- Regular exercise habits, defined as exercising at least 3 times per week, including at least 1 resistance-training session per week, with a stable exercise routine maintained during the previous 3 months.
- No cardiovascular, metabolic, neurological, or musculoskeletal diseases that would prevent safe participation in the exercise testing, as assessed by the research team.
- Not currently taking medications or dietary supplements that may affect blood coagulation.
- No known allergy to natto or soy products.
Who cannot join
- Current use of anticoagulant or antiplatelet medications.
- History of bleeding disorders or abnormal blood coagulation.
- Major surgery within the previous 3 months.
- Known cardiovascular, renal, or other major chronic diseases.
- History of severe lower-extremity musculoskeletal injury, such as fracture, ligament injury, or meniscal injury, when judged by the research team to make exercise testing inappropriate.
- Current acute inflammation, infection, or another physical condition considered unsuitable for participation in exercise.
- Participation in high-intensity or systematic plyometric training within the previous month.
- Students currently supervised by the principal investigator or individuals with a relevant conflict of interest with the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan, Taiwan, 333325
About this study
This pilot study aims to investigate whether 4 weeks of nattokinase supplementation (2,000 FU/day) affects recovery following exercise-induced muscle damage in healthy adult men. Approximately 12 to 16 participants aged 18 to 40 years will receive either nattokinase or a matching placebo during the supplementation period. After supplementation, participants will complete an exercise protocol designed to induce temporary muscle damage. Recovery will be evaluated using measures of muscle strength and exercise performance, muscle soreness, blood lactate, muscle oxygenation, and blood biomarkers related to muscle damage, inflammation, and oxidative stress. Measurements will be performed before and after the exercise-induced muscle damage protocol, including follow-up assessments during the recovery period. The study is intended to provide preliminary information on the potential effects of nattokinase supplementation on muscle recovery after strenuous exercise.
- Conditions
- Exercise-induced Muscle Damage
- Being tested
- Nattokinase, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NattokinaseDietary supplement
Participants will consume one capsule of nattokinase orally once daily, providing 2,000 FU/day, for 28 days.
PlaceboDietary supplement
Participants will consume one matching placebo capsule orally once daily for 28 days. The placebo is matched in appearance and flavor to the nattokinase supplement.
| Study group | Role | What they receive |
|---|---|---|
| Nattokinase Group | Experimental | Participants assigned to this arm will consume one capsule of nattokinase daily, providing 2,000 FU/day, for 28 days. Receives: Dietary Supplement: Nattokinase |
| Placebo Group | Placebo comparator | Participants assigned to this arm will consume one matching placebo capsule daily for 28 days. The placebo is matched in appearance and flavor to the nattokinase supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Force During Isometric Mid-Thigh Pull (IMTP)
Peak force during the isometric mid-thigh pull (IMTP) will be measured to assess maximal isometric strength. The highest value from three trials will be used for analysis.
Measured: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Countermovement Jump (CMJ) Height
Countermovement jump height will be measured to assess lower-limb explosive performance. The highest value from three trials will be used for analysis.
Measured: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood Lactate Concentration
Blood lactate concentration will be measured before and after the Wingate Anaerobic Test (WAnT) to assess lactate production and clearance. The WAnT will be used as a standardized high-intensity exercise stimulus.
Measured: During the Day 0, pre-EIMD, and immediately post-EIMD WAnT assessments; blood lactate will be measured before exercise, immediately after exercise, and at 3, 5, and 10 minutes post-exercise.
Muscle Oxygen Saturation (SmO₂)
Muscle oxygen saturation (SmO₂) will be measured using near-infrared spectroscopy (NIRS) to assess changes in muscle oxygenation.
Measured: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Total Hemoglobin (THb)
Total hemoglobin (THb) will be measured using near-infrared spectroscopy (NIRS) to assess changes in local muscle blood volume.
Measured: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD
Subjective Muscle Soreness Using Visual Analogue Scale (VAS)
Subjective muscle soreness will be assessed using a 100-mm visual analogue scale (VAS), ranging from no soreness to worst possible soreness.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Subjective Muscle Soreness Using Borg CR-10 Scale
Subjective muscle soreness will also be assessed using the Borg CR-10 scale, ranging from 0 to 10.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Pressure Pain Threshold (PPT)
Pressure pain threshold (PPT) will be measured at the vastus lateralis using a pressure algometer to objectively assess muscle soreness.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Creatine Kinase (CK) Concentration
Blood creatine kinase (CK) concentration will be measured as a marker of exercise-induced muscle damage.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Myoglobin Concentration
Blood myoglobin concentration will be measured as a marker of exercise-induced muscle damage.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Lactate Dehydrogenase (LDH) Concentration
Blood lactate dehydrogenase (LDH) concentration will be measured as a marker of exercise-induced muscle damage.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Blood high-sensitivity C-reactive protein (hs-CRP) concentration will be measured to assess the inflammatory response following EIMD.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Interleukin-6 (IL-6) Concentration
Blood interleukin-6 (IL-6) concentration will be measured to assess the inflammatory response following EIMD.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Tumor Necrosis Factor-Alpha (TNF-α) Concentration
Blood tumor necrosis factor-alpha (TNF-α) concentration will be measured to assess the inflammatory response following EIMD.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Malondialdehyde (MDA) Concentration
Blood malondialdehyde (MDA) concentration will be measured as a marker of oxidative stress.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Total Antioxidant Capacity (TAC)
Total antioxidant capacity (TAC) will be measured to assess antioxidant capacity following EIMD.
Measured: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Secondary outcomes (8)
Body Weight
Body weight will be measured using bioelectrical impedance analysis.
Measured: Day 0 baseline and Day 28.
Body Mass Index (BMI)
Body mass index (BMI) will be assessed using bioelectrical impedance analysis.
Measured: Day 0 baseline and Day 28.
Skeletal Muscle Mass
Skeletal muscle mass will be measured using bioelectrical impedance analysis.
Measured: Day 0 baseline and Day 28.
Skeletal Muscle Percentage
Skeletal muscle percentage will be measured using bioelectrical impedance analysis.
Measured: Day 0 baseline and Day 28.
Body Fat Mass
Body fat mass will be measured using bioelectrical impedance analysis.
Measured: Day 0 baseline and Day 28
Body Fat Percentage
Body fat percentage will be measured using bioelectrical impedance analysis.
Measured: Day 0 baseline and Day 28
Fat-Free Mass
Fat-free mass will be measured using bioelectrical impedance analysis.
Measured: Day 0 baseline and Day 28
Dietary Intake
Three-day dietary records will be used to assess habitual dietary intake. Total energy intake and macronutrient intake, including carbohydrate, protein, and fat, will be analyzed.
Measured: Three-day dietary records at Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start3 Sep 2026
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced Muscle DamageStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ju Hsu, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836634
- Sponsor's protocol ID
- NTSUIRB-115-102
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nattokinase Supplementation on Strength Recovery and Muscle Damage Biomarkers Following Exercise-Induced Muscle Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT07836634
- Acronym / sponsor ID
- NTSUIRB-115-102
- Conditions
- Exercise-induced Muscle Damage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 23 Sep 2026 (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.
This pilot study aims to investigate whether 4 weeks of nattokinase supplementation (2,000 FU/day) affects recovery following exercise-induced muscle damage in healthy adult men. Approximately 12 to 16 participants aged 18 to 40 years will receive either nattokinase or a matching placebo during the supplementation period. After supplementation, participants will complete an exercise protocol designed to induce temporary muscle damage. Recovery will be evaluated using measures of muscle strength and exercise performance, muscle soreness, blood lactate, muscle oxygenation, and blood biomarkers related to muscle damage, inflammation, and oxidative stress. Measurements will be performed before and after the exercise-induced muscle damage protocol, including follow-up assessments during the recovery period. The study is intended to provide preliminary information on the potential effects of nattokinase supplementation on muscle recovery after strenuous exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nattokinase Group | Experimental | Dietary Supplement: NattokinaseParticipants assigned to this arm will consume one capsule of nattokinase daily, providing 2,000 FU/day, for 28 days. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants assigned to this arm will consume one matching placebo capsule daily for 28 days. The placebo is matched in appearance and flavor to the nattokinase supplement. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male participants aged 18 to 40 years.
- Regular exercise habits, defined as exercising at least 3 times per week, including at least 1 resistance-training session per week, with a stable exercise routine maintained during the previous 3 months.
- No cardiovascular, metabolic, neurological, or musculoskeletal diseases that would prevent safe participation in the exercise testing, as assessed by the research team.
- Not currently taking medications or dietary supplements that may affect blood coagulation.
- No known allergy to natto or soy products.
Key exclusion criteria (8 listed)
- Current use of anticoagulant or antiplatelet medications.
- History of bleeding disorders or abnormal blood coagulation.
- Major surgery within the previous 3 months.
- Known cardiovascular, renal, or other major chronic diseases.
- History of severe lower-extremity musculoskeletal injury, such as fracture, ligament injury, or meniscal injury, when judged by the research team to make exercise testing inappropriate.
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 |
|---|---|---|
| NattokinaseParticipants will consume one capsule of nattokinase orally once daily, providing 2,000 FU/day, for 28 days. | Dietary supplement | Nattokinase Group |
| PlaceboParticipants will consume one matching placebo capsule orally once daily for 28 days. The placebo is matched in appearance and flavor to the nattokinase supplement. | Dietary supplement | Placebo Group |
Primary outcome
Peak Force During Isometric Mid-Thigh Pull (IMTP)
Time frame: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Peak force during the isometric mid-thigh pull (IMTP) will be measured to assess maximal isometric strength. The highest value from three trials will be used for analysis.
Countermovement Jump (CMJ) Height
Time frame: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Countermovement jump height will be measured to assess lower-limb explosive performance. The highest value from three trials will be used for analysis.
Blood Lactate Concentration
Time frame: During the Day 0, pre-EIMD, and immediately post-EIMD WAnT assessments; blood lactate will be measured before exercise, immediately after exercise, and at 3, 5, and 10 minutes post-exercise.
Blood lactate concentration will be measured before and after the Wingate Anaerobic Test (WAnT) to assess lactate production and clearance. The WAnT will be used as a standardized high-intensity exercise stimulus.
Muscle Oxygen Saturation (SmO₂)
Time frame: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Muscle oxygen saturation (SmO₂) will be measured using near-infrared spectroscopy (NIRS) to assess changes in muscle oxygenation.
Total Hemoglobin (THb)
Time frame: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD
Total hemoglobin (THb) will be measured using near-infrared spectroscopy (NIRS) to assess changes in local muscle blood volume.
Subjective Muscle Soreness Using Visual Analogue Scale (VAS)
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Subjective muscle soreness will be assessed using a 100-mm visual analogue scale (VAS), ranging from no soreness to worst possible soreness.
Subjective Muscle Soreness Using Borg CR-10 Scale
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Subjective muscle soreness will also be assessed using the Borg CR-10 scale, ranging from 0 to 10.
Pressure Pain Threshold (PPT)
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Pressure pain threshold (PPT) will be measured at the vastus lateralis using a pressure algometer to objectively assess muscle soreness.
Creatine Kinase (CK) Concentration
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood creatine kinase (CK) concentration will be measured as a marker of exercise-induced muscle damage.
Myoglobin Concentration
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood myoglobin concentration will be measured as a marker of exercise-induced muscle damage.
Lactate Dehydrogenase (LDH) Concentration
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood lactate dehydrogenase (LDH) concentration will be measured as a marker of exercise-induced muscle damage.
High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood high-sensitivity C-reactive protein (hs-CRP) concentration will be measured to assess the inflammatory response following EIMD.
Interleukin-6 (IL-6) Concentration
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood interleukin-6 (IL-6) concentration will be measured to assess the inflammatory response following EIMD.
Tumor Necrosis Factor-Alpha (TNF-α) Concentration
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood tumor necrosis factor-alpha (TNF-α) concentration will be measured to assess the inflammatory response following EIMD.
Malondialdehyde (MDA) Concentration
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood malondialdehyde (MDA) concentration will be measured as a marker of oxidative stress.
Total Antioxidant Capacity (TAC)
Time frame: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Total antioxidant capacity (TAC) will be measured to assess antioxidant capacity following EIMD.
8 secondary outcomes
Body Weight
Time frame: Day 0 baseline and Day 28.
Body Mass Index (BMI)
Time frame: Day 0 baseline and Day 28.
Skeletal Muscle Mass
Time frame: Day 0 baseline and Day 28.
Skeletal Muscle Percentage
Time frame: Day 0 baseline and Day 28.
Body Fat Mass
Time frame: Day 0 baseline and Day 28
Body Fat Percentage
Time frame: Day 0 baseline and Day 28
Fat-Free Mass
Time frame: Day 0 baseline and Day 28
Dietary Intake
Time frame: Three-day dietary records at Day 0 and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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 Nattokinase in people with Exercise-induced Muscle Damage, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Peak Force During Isometric Mid-Thigh Pull (IMTP) (time frame: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.