AerobicFUNNCT07310108
Evaluation of Cordyceps Militaris M2-116-04 for Its Potential Sport and Exercise Nutrition Applications in Healthy Active Adults
A study testing Cordyceps Militaris in people with Aerobic and Exercise, run by Lindenwood University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of supplementation with Cordyceps militaris MS-116-04 on exercise performance, endurance, cardiovascular fitness, gastrointestinal wellness, mood, and recovery compared to a placebo in healthy active adults. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Cordyceps Militaris
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 7 Nov 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 20 to 50 years of age. Individual indicates they are currently engaged in and historically engaged in exercise (i.e., structured or unstructured) for the prior 12 months.
- Subject has the ability to exercise on a cycle ergometer without issue or concern.
- Subject has the ability to "sprint" (cycle Time to Exhaustion Trial) without any orthopedic or other limitations.
- Body Mass Index (BMI) 19 to 29.9 kg/m2 (normal weight to overweight status) Subject is in good health and appropriate for exercise as determined by physical examination, medical history and the Physical Activity Readiness Questionnaire (PAR-Q).
- Subject can exercise on a cycle ergometer without issue or concern. Subject is a non-smoker. Subject agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to the exercise test visits.
- Subject is willing and able to comply with the protocol including: attending the study scheduled appointments, of which two of the study visits may take up to five hours for completion.
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- Subject agrees to refrain from exercise for the 24 hours prior to any test visits.
- Subject agrees to refrain from alcohol use for at least 24 hours before every study visit.
- Subject agrees to refrain from using any antihistamines for the 24 hours prior to the exercise test visits.
- Subject agrees to refrain from drinking any exercise recovery beverages during the study period.
- Subject is able to understand and sign the informed consent to participate in the study.
Who cannot join
- Subject has any of the following medical conditions: active heart disease, uncontrolled high blood pressure (≥ 140/90 mmHg), renal or hepatic impairment/disease, Type I or II diabetes, bipolar disorder, Parkinson's disease, unstable thyroid disease, immune disorder (such as HIV/AIDS), any medical condition deemed exclusionary by the Principal Investigator (PI) Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- Subject has a medical condition or orthopedic problem making exercising on a cycle ergometer contraindicated.
- Subject has a VO2 peak/max value above the following age/sex categorizations (as measured during Visit 1): Males 20-29y - 47.5 mL/kg/min, Males 30-39y - 46.0 mL/kg/min, Males 40-45y - 43.9 mL/kg/min, Females 20-29y - 41.0 mL/kg/min, Females 30-39y - 39.6 mL/kg/min, Females 40-45y - 38.1 mL/kg/min Subject is currently taking antihypertensives, hypoglycemic medications or stimulatory asthma medications.
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Subject is taking a prescription medication deemed exclusionary by the Principal Investigator (PI).
- Subject has an allergy to any ingredients in the Study Product. Subject has a history of drug or alcohol abuse in the past 12 months. Subject has a history of a psychiatric illness requiring hospitalization in the past 12 months.
- Subject has any condition or abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.
- Subject is participating in or has participated in another research study within 30 days prior to the Screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindenwood University Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
Official title: A Randomized Double-Blind Parallel-Group Placebo Controlled Clinical Trial of Cordyceps Militaris M2-116-04 for Its Potential Sport and Exercise Nutrition Applications in Healthy Active Adults
The purpose of this study is to examine the effects of supplementation with Cordyceps militaris MS-116-04 on exercise performance, endurance, cardiovascular fitness, gastrointestinal wellness, mood, and recovery compared to a placebo in healthy active adults.
Read the detailed description
This randomized, double-blind, placebo-controlled trial will evaluate the effects of daily supplementation with Cordyceps militaris MS-116-04 on exercise performance, endurance, cardiovascular fitness, gastrointestinal wellness, mood, and post-exercise recovery in healthy, active adults.
Participants will complete five study visits over approximately four weeks. Before each visit, participants will follow standardized pre-visit controls, including an 8-10 hour fast, 12 hours without caffeine, nicotine, or alcohol, and 24 hours of no structured exercise.
Visit 1 (Screening/Familiarization) includes informed consent, medical and medication review, anthropometrics, body composition (InBody), screening questionnaires, and familiarization with all exercise testing procedures (VO2max/peak test, 30-minute cycling bout, and Time to Exhaustion [TTE] trial).
Visit 2 (Baseline Part A) includes medication review, questionnaires (SHS-GI, PANAS), adverse event monitoring, and a maximal cycling VO2max/peak test.
Visit 3 (Baseline Part B) includes resting blood samples (serum cortisol, amylase, TNF-α, IL-10), a 30-minute cycling bout at 60% VO2peak, a cycling TTE trial, Borg RPE, and additional blood sampling immediately and four hours post-exercise. A standardized carbohydrate snack is provided during the four-hour recovery period. Participants are then randomized and receive instructions for daily supplementation and compliance tracking.
Visit 4 (End-of-Study Part A; 28-30 days later) mirrors Visit 2 and includes questionnaires, adverse-event review, and a VO2max/peak test.
Visit 5 (End-of-Study Part B; ~72 hours later) replicates Visit 3, including all blood sampling, the 30-minute cycling bout, TTE trial, four-hour recovery period, and standardized snack. Supplement return and compliance calculations are completed at this visit.
- Being tested
- Cordyceps Militaris, Placebo
- Keywords
- aerobic, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordyceps MilitarisDietary supplement
Cordyceps Militaris Study Product
PlaceboOther
Maltodextrin placebo
| Study group | Role | What they receive |
|---|---|---|
| Study Product | Experimental | Cordyceps Militaris Receives: Dietary Supplement: Cordyceps Militaris |
| Placebo | Placebo comparator | Placebo maltodextrin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time to Exhaustion (TTE)
To determine whether supplementation with Cordyceps militaris MS-116-04, compared to placebo, affects exercise performance as measured by change from baseline in cycling Time to Exhaustion (TTE), recorded in minutes and seconds.
Measured: Baseline (Visit 3) to End of Study (Visit 5; approximately 4 weeks).
Change in VO2max
To determine whether Cordyceps militaris MS-116-04 affects cardiovascular fitness compared to placebo, as assessed by change in maximal or peak oxygen consumption (VO2max/peak) from baseline to the end of the study.
Measured: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks).
Change in Gastrointestinal Wellness (SHS-GI Score)
To assess whether the Study Product, compared to placebo, impacts digestive and gastrointestinal wellness as measured by the change in Short Health Scale for Gastrointestinal Symptoms (SHS-GI) total score from baseline to end of study.
The SHS-GI is a validated patient-reported outcome measure consisting of four items, each rated on a 7-point likert scale ranging from 1 to 7, resulting in a total score range of 4 to 28.
- Higher scores indicate worse gastrointestinal symptoms and poorer gastrointestinal well-being.
- Lower scores indicate fewer gastrointestinal symptoms and better gastrointestinal well-being.
Measured: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks).
Change in Mood States (PANAS Score)
To evaluate whether Cordyceps militaris MS-116-04 influences mood compared to placebo, as assessed by change in Positive and Negative Affect Schedule (PANAS) scores.
The PANAS is a validated self-report questionnaire consisting of 20 items, comprising two subscales: positive affect and negative affect. Each item is rated on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely).
- Positive affect subscale score range: 10 to 50. Higher scores indicate greater positive affect (better mood).
- Negative affect subscale score range: 10 to 50. Higher scores indicate greater negative affect (worse mood).
Measured: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks)
Change in Stress Cortisol Across Recovery Period
To determine whether the Study Product affects biomarker salivary cortisol measured at rest, immediately post-TTE, and four hours post-TTE.
Measured: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
Change in Salivary Amylase Across Recovery Period
To determine whether the Study Product affects biomarker salivary amylase measured at rest, immediately post-TTE, and four hours post-TTE.
Measured: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
Change in TNF-α
To determine whether the Study Product, compared to placebo, influences inflammatory responses as measured by salivary Tumor Necrosis Factor-alpha (TNF-α) collected pre-exercise, immediately post-exercise, and four hours post-exercise.
Measured: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
Change in IL-10 concentrations
To determine whether the Study Product, compared to placebo, influences inflammatory responses as measured by Interleukin-10 (IL-10) collected pre-exercise, immediately post-exercise, and four hours post-exercise.
Measured: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start21 May 2025
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AerobicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310108
- Sponsor's protocol ID
- IRB-25-28
- Acronym
- FUN
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Parallel-Group Placebo Controlled Clinical Trial of Cordyceps Militaris M2-116-04 for Its Potential Sport and Exercise Nutrition Applications in Healthy Active Adults
- ClinicalTrials.gov ID
- NCT07310108
- Acronym / sponsor ID
- FUN / IRB-25-28
- Keywords
- aerobic, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 30 Dec 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 purpose of this study is to examine the effects of supplementation with Cordyceps militaris MS-116-04 on exercise performance, endurance, cardiovascular fitness, gastrointestinal wellness, mood, and recovery compared to a placebo in healthy active adults.
Detailed description
This randomized, double-blind, placebo-controlled trial will evaluate the effects of daily supplementation with Cordyceps militaris MS-116-04 on exercise performance, endurance, cardiovascular fitness, gastrointestinal wellness, mood, and post-exercise recovery in healthy, active adults.
Participants will complete five study visits over approximately four weeks. Before each visit, participants will follow standardized pre-visit controls, including an 8-10 hour fast, 12 hours without caffeine, nicotine, or alcohol, and 24 hours of no structured exercise.
Visit 1 (Screening/Familiarization) includes informed consent, medical and medication review, anthropometrics, body composition (InBody), screening questionnaires, and familiarization with all exercise testing procedures (VO2max/peak test, 30-minute cycling bout, and Time to Exhaustion [TTE] trial).
Visit 2 (Baseline Part A) includes medication review, questionnaires (SHS-GI, PANAS), adverse event monitoring, and a maximal cycling VO2max/peak test.
Visit 3 (Baseline Part B) includes resting blood samples (serum cortisol, amylase, TNF-α, IL-10), a 30-minute cycling bout at 60% VO2peak, a cycling TTE trial, Borg RPE, and additional blood sampling immediately and four hours post-exercise. A standardized carbohydrate snack is provided during the four-hour recovery period. Participants are then randomized and receive instructions for daily supplementation and compliance tracking.
Visit 4 (End-of-Study Part A; 28-30 days later) mirrors Visit 2 and includes questionnaires, adverse-event review, and a VO2max/peak test.
Visit 5 (End-of-Study Part B; ~72 hours later) replicates Visit 3, including all blood sampling, the 30-minute cycling bout, TTE trial, four-hour recovery period, and standardized snack. Supplement return and compliance calculations are completed at this visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Product | Experimental | Dietary Supplement: Cordyceps MilitarisCordyceps Militaris |
| Placebo | Placebo comparator | Other: PlaceboPlacebo maltodextrin |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males and females aged 20 to 50 years of age. Individual indicates they are currently engaged in and historically engaged in exercise (i.e., structured or unstructured) for the prior 12 months.
- Subject has the ability to exercise on a cycle ergometer without issue or concern.
- Subject has the ability to "sprint" (cycle Time to Exhaustion Trial) without any orthopedic or other limitations.
- Body Mass Index (BMI) 19 to 29.9 kg/m2 (normal weight to overweight status) Subject is in good health and appropriate for exercise as determined by physical examination, medical history and the Physical Activity Readiness Questionnaire (PAR-Q).
- Subject can exercise on a cycle ergometer without issue or concern. Subject is a non-smoker. Subject agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to the exercise test visits.
Key exclusion criteria (8 listed)
- Subject has any of the following medical conditions: active heart disease, uncontrolled high blood pressure (≥ 140/90 mmHg), renal or hepatic impairment/disease, Type I or II diabetes, bipolar disorder, Parkinson's disease, unstable thyroid disease, immune disorder (such as HIV/AIDS), any medical condition deemed exclusionary by the Principal Investigator (PI) Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- Subject has a medical condition or orthopedic problem making exercising on a cycle ergometer contraindicated.
- Subject has a VO2 peak/max value above the following age/sex categorizations (as measured during Visit 1): Males 20-29y - 47.5 mL/kg/min, Males 30-39y - 46.0 mL/kg/min, Males 40-45y - 43.9 mL/kg/min, Females 20-29y - 41.0 mL/kg/min, Females 30-39y - 39.6 mL/kg/min, Females 40-45y - 38.1 mL/kg/min Subject is currently taking antihypertensives, hypoglycemic medications or stimulatory asthma medications.
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Subject is taking a prescription medication deemed exclusionary by the Principal Investigator (PI).
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 |
|---|---|---|
| Cordyceps MilitarisCordyceps Militaris Study Product | Dietary supplement | Study Product |
| PlaceboMaltodextrin placebo | Other | Placebo |
Primary outcome
Change in Time to Exhaustion (TTE)
Time frame: Baseline (Visit 3) to End of Study (Visit 5; approximately 4 weeks).
To determine whether supplementation with Cordyceps militaris MS-116-04, compared to placebo, affects exercise performance as measured by change from baseline in cycling Time to Exhaustion (TTE), recorded in minutes and seconds.
Change in VO2max
Time frame: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks).
To determine whether Cordyceps militaris MS-116-04 affects cardiovascular fitness compared to placebo, as assessed by change in maximal or peak oxygen consumption (VO2max/peak) from baseline to the end of the study.
Change in Gastrointestinal Wellness (SHS-GI Score)
Time frame: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks).
To assess whether the Study Product, compared to placebo, impacts digestive and gastrointestinal wellness as measured by the change in Short Health Scale for Gastrointestinal Symptoms (SHS-GI) total score from baseline to end of study. The SHS-GI is a validated patient-reported outcome measure consisting of four items, each rated on a 7-point likert scale ranging from 1 to 7, resulting in a total score range of 4 to 28. * Higher scores indicate worse gastrointestinal symptoms and poorer gastrointestinal well-being. * Lower scores indicate fewer gastrointestinal symptoms and better gastrointestinal well-being.
Change in Mood States (PANAS Score)
Time frame: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks)
To evaluate whether Cordyceps militaris MS-116-04 influences mood compared to placebo, as assessed by change in Positive and Negative Affect Schedule (PANAS) scores. The PANAS is a validated self-report questionnaire consisting of 20 items, comprising two subscales: positive affect and negative affect. Each item is rated on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). * Positive affect subscale score range: 10 to 50. Higher scores indicate greater positive affect (better mood). * Negative affect subscale score range: 10 to 50. Higher scores indicate greater negative affect (worse mood).
Change in Stress Cortisol Across Recovery Period
Time frame: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
To determine whether the Study Product affects biomarker salivary cortisol measured at rest, immediately post-TTE, and four hours post-TTE.
Change in Salivary Amylase Across Recovery Period
Time frame: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
To determine whether the Study Product affects biomarker salivary amylase measured at rest, immediately post-TTE, and four hours post-TTE.
Change in TNF-α
Time frame: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
To determine whether the Study Product, compared to placebo, influences inflammatory responses as measured by salivary Tumor Necrosis Factor-alpha (TNF-α) collected pre-exercise, immediately post-exercise, and four hours post-exercise.
Change in IL-10 concentrations
Time frame: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
To determine whether the Study Product, compared to placebo, influences inflammatory responses as measured by Interleukin-10 (IL-10) collected pre-exercise, immediately post-exercise, and four hours post-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 30 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Chad M Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cordyceps Militaris in people with Aerobic and Exercise, run by Lindenwood University at 1 site 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 11 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 30 Dec 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 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. 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 Time to Exhaustion (TTE) (time frame: Baseline (Visit 3) to End of Study (Visit 5; approximately 4 weeks).). The study lists 8 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 30 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.