A Trial to Study the Effects of Ginseng and Cordyceps on Aerobic Capacity, Lactate Kinetics, and Nitric Oxide
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorApplied Food Sciences Inc.
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
Panax ginseng
Dietary supplementPanax Ginseng extract standardized to 5% ginsenosides
Cordycep Militaris
Dietary supplementCordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%
Placebo
Other intervention1 gram maltodextrin to mirror 1 gram capsule active
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: GinsengExperimental treatment 1 intervention
Group B: CordycepsActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and Day 302
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 303
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 304
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 30Secondary outcomes
1
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 302
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 303
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 304
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 30Other outcomes
1
Study product subject safety intake over 30 days
Heart rate will be measured using an automated sphygmomanometer (Omron HEM907XL) measured in beats per minute.
Time frame
Day 1, Day 7, Day 14, Day 21, Day 302
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.
Time frame
For study period, up to 45 days3
Study product safety intake over 30 days
Blood pressure will be measured using an automated sphygmomanometer (Omron HEM907XL) measures in mmHg (millimeters of mercury)
Time frame
Day 1, Day 7, Day 14, Day 21, Day 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Applied Food Sciences Inc.
Lead sponsor
The Center for Applied Health Sciences, LLC
Collaborator
Source ClinicalTrials.gov