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NCT Number: NCT07729943

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location status: Recruiting

Location contact

Jennifer Sandrock, MS RD, CCRC

CONTACT

[email protected]

330.926.6927

Michael La Monica, Ph.D., CSCS

PRINCIPAL_INVESTIGATOR

Tim N Ziegenfuss, PhD, CSCS, FISSN

CONTACT

[email protected]

330.926.6927

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panax ginseng

Dietary Supplement

Panax Ginseng extract standardized to 5% ginsenosides

Cordycep Militaris

Dietary Supplement

Cordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%

Other names: Cordycep mushroom extract, MycoThrive Cordycep Extract

Placebo

Other

1 gram maltodextrin to mirror 1 gram capsule active

Primary outcomes

  1. Change in VO2 max from baseline to day 30

    Time frame: Baseline and 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

  2. Change in ventilatory threshold

    Time frame: Baseline Day 1 and then Day 30

    ventilatory threshold (VT) is measured using the The Professional Method (CPET) using the Oxygen consumption data (VO2) measured using an indirect calorimeter

  3. Change in Circulatory efficiency (oxygen pulse) over 30 days

    Time frame: Baseline Day 1, then Day 30

    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

  4. Change in Time-to-Exhaustion (TTE) over 30 days

    Time frame: Day 1 and Day 30

    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.

Secondary outcomes

  1. Change in Handgrip Strength over 30 days

    Time frame: Day 1, then at Day 30

    Between and within-group changes in handgrip strength using an isometric hand grip measured with a Jamar hand dynamometer.

  2. Change in Isometric Mid-Thigh Pull Peak Force over 30 days

    Time frame: Day 1, then Day 30

    Between and within-group changes in isometric mid-thigh pull (IMTP) peak force measured with the PASCO force platform.

  3. Change in Lactate Kinetics over 30 days

    Time frame: Day 1, then Day 30

    Between and within-group changes in lactate kinetics (production and clearance) measured with a Lactate Plus Meter

  4. Change in Total Nitrates / Nitrites (NOx) over 30 days

    Time frame: Day 1 then Day 30

    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).

  5. Change in Quality of life questionnaire (SF-36) over 30 days

    Time frame: Day 1, Day 7, Day 14, Day 21, Day 30

    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.

  6. Change in Profile Mood States (POMS) over 30 days

    Time frame: Day 1, Day 7, Day 14, Day 21, Day 30

    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).

  7. Change in Visual Analog Score (VAS) over 30 days

    Time frame: Day 1, Day 7, Day 14, Day 21, Day 30

    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)

  8. Change in Perceived Recovery Scale (PRS) over 30 days

    Time frame: Day 1, Day 7, Day 14, Day 21, Day 30

    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)

Other outcomes

  1. Study product subject safety intake over 30 days

    Time frame: Day 1, Day 7, Day 14, Day 21, Day 30

    Heart rate will be measured using an automated sphygmomanometer (Omron HEM907XL) measured in beats per minute.

  2. Adverse Effects

    Time frame: For study period, up to 45 days

    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.

  3. Study product safety intake over 30 days

    Time frame: Day 1, Day 7, Day 14, Day 21, Day 30

    Blood pressure will be measured using an automated sphygmomanometer (Omron HEM907XL) measures in mmHg (millimeters of mercury)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Michael La Monica, Ph.D., CSCS

CONTACT

[email protected]

330.926.6927

Tim N Ziegenfuss, PhD, CSCS, FISSN

CONTACT

[email protected]

330.926.6927

Sponsors and collaborators

Lead sponsor

Applied Food Sciences Inc.

Industry

Collaborators

  • The Center for Applied Health Sciences, LLC

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.