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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ginseng 		250 mg Panax Ginseng extract
  • Dietary Supplement: Panax ginseng
    Panax Ginseng extract standardized to 5% ginsenosides
Active Comparator
Cordyceps 		1 gram cordyceps militaris fruiting body mushroom extract
  • Dietary Supplement: Cordycep Militaris
    Cordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%
    Other names:
    • Cordycep mushroom extract
    • MycoThrive Cordycep Extract
Placebo Comparator
Placebo 		Maltodextrin
  • Other: Placebo
    1 gram maltodextrin to mirror 1 gram capsule active

Recruiting Locations

The Center for Applied Health Sciences
Canfield, Ohio 44406
Contact:
Jennifer Sandrock, MS RD, CCRC
330.926.6927
jh@appliedhealthsciences.org

More Details

Status
Recruiting
Sponsor
Applied Food Sciences Inc.

Study Contact

Michael Michael La Monica, Ph.D., CSCS
330.926.6927
ml@appliedhealthsciences.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.