NCT07729943

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Mar 2026Feb 2027

Study Start

First participant enrolled

March 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

June 22, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

Cordyceps (Cordyceps Militaris)Panax GinsengVO2MaxNOxCirculatory efficiency

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • Change in Handgrip Strength over 30 days

    Day 1, then at Day 30

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

    Day 1, then Day 30

  • Change in Lactate Kinetics over 30 days

    Day 1, then Day 30

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

    Day 1 then Day 30

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

    Day 1, Day 7, Day 14, Day 21, Day 30

  • +3 more secondary outcomes

Other Outcomes (3)

  • Study product subject safety intake over 30 days

    Day 1, Day 7, Day 14, Day 21, Day 30

  • Adverse Effects

    For study period, up to 45 days

  • Study product safety intake over 30 days

    Day 1, Day 7, Day 14, Day 21, Day 30

Study Arms (3)

Ginseng

EXPERIMENTAL

250 mg Panax Ginseng extract

Dietary Supplement: Panax ginseng

Cordyceps

ACTIVE COMPARATOR

1 gram cordyceps militaris fruiting body mushroom extract

Dietary Supplement: Cordycep Militaris

Placebo

PLACEBO COMPARATOR

Maltodextrin

Other: Placebo

Interventions

Panax ginsengDIETARY_SUPPLEMENT

Panax Ginseng extract standardized to 5% ginsenosides

Ginseng
Cordycep MilitarisDIETARY_SUPPLEMENT

Cordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%

Also known as: Cordycep mushroom extract, MycoThrive Cordycep Extract
Cordyceps
PlaceboOTHER

1 gram maltodextrin to mirror 1 gram capsule active

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

RECRUITING

MeSH Terms

Interventions

Asian ginseng

Central Study Contacts

Michael Michael La Monica, Ph.D., CSCS

CONTACT

Tim N Ziegenfuss, PhD, CSCS, FISSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 28, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Confidentiality

Locations