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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
32
Cordyceps Militaris Study Product
Maltodextrin placebo
Lindenwood University Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (Visit 2) to End of Study (Visit 4; approximately 4 weeks)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.