Evaluation of Cordyceps Militaris M2-116-04 for Its Potential Sport and Exercise Nutrition Applic… (NCT07310108) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Cordyceps Militaris M2-116-04 for Its Potential Sport and Exercise Nutrition Applications in Healthy Active Adults
United States32 participantsStarted 2025-05-21
Plain-language 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.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
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 exer…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Time to Exhaustion (TTE)
Timeframe: Baseline (Visit 3) to End of Study (Visit 5; approximately 4 weeks).
2
Change in VO2max
Timeframe: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks).
3
Change in Gastrointestinal Wellness (SHS-GI Score)
Timeframe: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks).
4
Change in Mood States (PANAS Score)
Timeframe: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks)
5
Change in Stress Cortisol Across Recovery Period
Timeframe: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.
6
Change in Salivary Amylase Across Recovery Period
Timeframe: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.