A Trial to Study the Effects of Ginseng and Cordyceps on Aerobic Capacity, Lactate Kinetics, and Nitric Oxide

Comparative Effects of Ginseng, Cordyceps, and Placebo on Aerobic Capacity, Lactate Kinetics, and Nitric Oxide Status: A 30-Day Randomized Trial

This study is a double-blind, randomized, parallel group, three-arm, placebo-controlled trial of seventy-five (75) apparently healthy male and female participants to be recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). The study will assess the potential benefits of four weeks of supplementation with 300 mg Ginseng or 1 gram Cordyceps Militaris (vs. placebo). Participants will attend 3 study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet and familiarization protocol will be completed). During Visit 2 (Day 0) and Visit 3 (Day 30) participants will complete subjective baseline testing including questionnaires that assess recovery, mood, energy, fatigue, and quality of life. They will complete a VO2 max test, a TTE test, isometric mid-thigh pull, and have their handgrip strength assessed. They will also be tested for changes in circulating nitrates/nitrites (NOx), circulatory efficiency (oxygen pulse), and lactate kinetics (production and clearance).

Comprehensive side effect profile/ adverse event monitoring will take place throughout thevstudy duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects With Low Energy Levels
• Intervention / Treatment: Dietary supplement: Panax ginseng; Dietary supplement: Cordycep Militaris; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Michael La Monica, Ph.D., CSCS; Phone Number: 330.926.6927; Email: ml@appliedhealthsciences.org
• Study Contact Backup: Name: Tim N Ziegenfuss, PhD, CSCS, FISSN; Phone Number: 330.926.6927; Email: tz@appliedhealthsciences.org

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • Recruiting
      • The Center for Applied Health Sciences
      • Contact: Tim N Ziegenfuss, PhD, CSCS, FISSN; Phone Number: 330.926.6927; Email: tz@appliedhealthsciences.org
      • Contact: Jennifer Sandrock, MS RD, CCRC; Phone Number: 330.926.6927; Email: jh@appliedhealthsciences.org
      • Principal Investigator: Michael La Monica, Ph.D., CSCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provide voluntary signed and dated informed consent.

  • Be in good health and able to participate in cognitive performance testing as determined by assessment, medical history, and routine blood chemistries.
  • Between the of 40 and 65 years of age (inclusive).
  • Body Mass Index of 18.5-34.9 (inclusive).
  • Body weight of at least 110 pounds.
  • Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
  • Normal supine, resting heart rate (<90 per minute).
  • Able to provide an adequate blood draw.
  • If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
  • Willing to duplicate their previous 24-hour diet, refrain from caffeine and alcohol for 24 hours, refrain from exercise for 48 hours prior to each trial, and fast for 10 hours prior to each visit.
  • Recreationally active (≥3 exercise sessions/wk)

Exclusion Criteria:

-Smokers.

• History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Prior gastrointestinal bypass surgery (Lapband, etc.).
• Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic medically diagnosed inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• Medical history of metabolic, cardiovascular, hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
• Use of performance enhancing drugs
• Anti-inflammatory supplement/medication use started within 4 weeks
• Ergogenic supplement use started within 4 weeks. (i.e. beta-alanine, creatine, beet root, citrulline, arginine, )
• Individuals with excessive caffeine intake (>400mg/day).
• Known sensitivity to any ingredient in the test formulations as listed in the Certificates- of-Analysis.
• Women currently pregnant, trying to become pregnant or breastfeeding a child.
• Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Other: Placebo; 1 gram maltodextrin to mirror 1 gram capsule active
Experimental: Ginseng; 250 mg Panax Ginseng extract	Dietary supplement: Panax ginseng; Panax Ginseng extract standardized to 5% ginsenosides
Active Comparator: Cordyceps; 1 gram cordyceps militaris fruiting body mushroom extract	Dietary supplement: Cordycep Militaris; Cordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%; Other Names: Cordycep mushroom extract; MycoThrive Cordycep Extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VO2 max from baseline to day 30	Between and within-group changes in maximal aerobic capacity (VO2 max). Oxygen consumption (VO2) for the maximal aerobic capacity test will be measured using an indirect calorimeter	Baseline and Day 30
Change in ventilatory threshold	ventilatory threshold (VT) is measured using the The Professional Method (CPET) using the Oxygen consumption data (VO2) measured using an indirect calorimeter	Baseline Day 1 and then Day 30
Change in Circulatory efficiency (oxygen pulse) over 30 days	Between and within-group changes in maximal in circulatory efficiency (oxygen pulse). Circulatory efficiency (oxygen pulse) will be calculated as the ratio of oxygen uptake (VO2) to heart rate at two time points: @VO2max and @VT	Baseline Day 1, then Day 30
Change in Time-to-Exhaustion (TTE) over 30 days	Between and within-group changes in time-to-exhaustion (TTE). A cycle ergometer will be used for all cycling exercise sessions and contain a digital time reading.	Day 1 and Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Handgrip Strength over 30 days	Between and within-group changes in handgrip strength using an isometric hand grip measured with a Jamar hand dynamometer.	Day 1, then at Day 30
Change in Isometric Mid-Thigh Pull Peak Force over 30 days	Between and within-group changes in isometric mid-thigh pull (IMTP) peak force measured with the PASCO force platform.	Day 1, then Day 30
Change in Lactate Kinetics over 30 days	Between and within-group changes in lactate kinetics (production and clearance) measured with a Lactate Plus Meter	Day 1, then Day 30
Change in Total Nitrates / Nitrites (NOx) over 30 days	Between and within-group changes in total nitrates/nitrites (NOx). Total nitrates/nitrites in serum/plasma (NOx) will be sent for third party analysis Pre- exercise baseline (PRE) samples will be taken after a 10-15 min seated rest, before any testing. POST samples will be taken post-VO₂max (POST-VO₂max), 10 min after the VO2max test has been completed (quiet, no movement).	Day 1 then Day 30
Change in Quality of life questionnaire (SF-36) over 30 days	Subjective measures of recovery, mood, energy, fatigue and quality of life. Short Form 36 will be measured using a standardized, validated questionnaire with standardized scores ranging from 0 to 100 with higher numbers indicating better health.	Day 1, Day 7, Day 14, Day 21, Day 30
Change in Profile Mood States (POMS) over 30 days	Profile of Mood States 2nd edition (POMS2). Profile mood state raw scores are converted into standardized T-scores (mean = 50, standard deviation = 10) to compare an individual against standardized normative data. The values represent an individual's rating (on a 5-point Likert scale from 0 = Not at all to 4 = Extremely).	Day 1, Day 7, Day 14, Day 21, Day 30
Change in Visual Analog Score (VAS) over 30 days	The Visual Analog Scale (VAS) is a continuous, 10 cm line tool capped by extreme symptom anchors (e.g., "no pain" to "worst pain") used by patients to self-report the precise intensity of highly subjective conditions like pain, fatigue, and anxiety. (NIH)	Day 1, Day 7, Day 14, Day 21, Day 30
Change in Perceived Recovery Scale (PRS) over 30 days	The Perceived Recovery Scale (PRS) [3] is a single-item, 0- to 10-point scale with 2 sets of verbal anchors defining the numerical indicators of both recovery and expected performance, where 0 = very poorly recovered (poor performance) and 10 = fully recovered (optimal performance)	Day 1, Day 7, Day 14, Day 21, Day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study product subject safety intake over 30 days	Heart rate will be measured using an automated sphygmomanometer (Omron HEM907XL) measured in beats per minute.	Day 1, Day 7, Day 14, Day 21, Day 30
Adverse Effects	All local and systemic non-serious and serious adverse events (AEs) observed by or reported by the investigators will be evaluated and assessed through reports coded using the Medical Dictionary for Regulatory Activities (MedDRA). The intensity of an AE will be graded according to the protocol-defined criteria based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, 2017.	For study period, up to 45 days
Study product safety intake over 30 days	Blood pressure will be measured using an automated sphygmomanometer (Omron HEM907XL) measures in mmHg (millimeters of mercury)	Day 1, Day 7, Day 14, Day 21, Day 30

Collaborators and Investigators

• Sponsor: Applied Food Sciences Inc.
• Collaborators: The Center for Applied Health Sciences, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: NOx; VO2Max; Panax Ginseng; Cordyceps (Cordyceps Militaris); Circulatory efficiency
• Additional Relevant MeSH Terms: Asian ginseng
• Other Study ID Numbers: AFS-002-2025CG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No