Evaluation of Cordyceps Militaris M2-116-04 for Its Potential Sport and Exercise Nutrition Applications in Healthy Active Adults

NCT07310108 | Completed

• 1 other identifier: IRB-25-28
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aerobic; Exercise

Keywords

aerobic; exercise

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  Pre-exercise (resting), immediately post-exercise, and 4 hours post-exercise at baseline and after approximately 4 weeks of intervention.

Study Arms (2)

Study Product

EXPERIMENTAL

Cordyceps Militaris

Dietary Supplement: Cordyceps Militaris

Placebo

PLACEBO COMPARATOR

Placebo maltodextrin

Other: Placebo

Interventions

Cordyceps Militaris DIETARY_SUPPLEMENT

Cordyceps Militaris Study Product

Study Product

Placebo OTHER

Maltodextrin placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 exercise recovery beverages during the study period.
• Subject is able to understand and sign the informed consent to participate in the study.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Lindenwood University Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

CMIP protein, Cordyceps militaris

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo (maltodextrin) or Study Product (Cordyceps Militaris). The serving size is 3 capsules taken once per day, with or without food. The Placebo will match the Study Product in appearance, color, and format. All supplements will be in capsule form and provided by the sponsor.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 30, 2025
• Study Start: May 21, 2025
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)