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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
75
Panax Ginseng extract standardized to 5% ginsenosides
Cordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%
1 gram maltodextrin to mirror 1 gram capsule active
The Center for Applied Health Sciences
Canfield, Ohio, United States
RECRUITINGChange 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 1 and Day 30
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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: Day 1, Day 7, Day 14, Day 21, Day 30
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