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
Qualifiers
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
Treatments tested in this trial
- Panax ginseng
- Cordycep Militaris
- Placebo
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Applied Food Sciences Inc.
Lead sponsor
The Center for Applied Health Sciences, LLC
Collaborator
Source ClinicalTrials.gov