NCT07310108

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Lindenwood University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Aerobic
• Exercise

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cordyceps Militaris	Cordyceps Militaris Study Product
OTHER	Placebo	Maltodextrin placebo

Timeline

• Start date: 2025-05-21
• Primary completion: 2025-11-07
• Completion: 2025-11-07
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States