Healthy Subjects With Low Energy Levels
Conditions
Keywords
Cordyceps (Cordyceps Militaris), Panax Ginseng, VO2Max, NOx, Circulatory efficiency
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.
Interventions
DIETARY_SUPPLEMENTPanax ginseng
Panax Ginseng extract standardized to 5% ginsenosides
DIETARY_SUPPLEMENTCordycep Militaris
Cordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%
OTHERPlacebo
1 gram maltodextrin to mirror 1 gram capsule active
Sponsors
Applied Food Sciences Inc.
The Center for Applied Health Sciences, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO2 max from baseline to day 30 | Baseline and 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 |
| Change in ventilatory threshold | Baseline Day 1 and then Day 30 | ventilatory threshold (VT) is measured using the The Professional Method (CPET) using the Oxygen consumption data (VO2) measured using an indirect calorimeter |
| Change in Circulatory efficiency (oxygen pulse) over 30 days | Baseline Day 1, then Day 30 | 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 |
| Change in Time-to-Exhaustion (TTE) over 30 days | Day 1 and Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Handgrip Strength over 30 days | Day 1, then at Day 30 | Between and within-group changes in handgrip strength using an isometric hand grip measured with a Jamar hand dynamometer. |
| Change in Isometric Mid-Thigh Pull Peak Force over 30 days | Day 1, then Day 30 | Between and within-group changes in isometric mid-thigh pull (IMTP) peak force measured with the PASCO force platform. |
| Change in Lactate Kinetics over 30 days | Day 1, then Day 30 | Between and within-group changes in lactate kinetics (production and clearance) measured with a Lactate Plus Meter |
| Change in Total Nitrates / Nitrites (NOx) over 30 days | Day 1 then Day 30 | 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). |
| Change in Quality of life questionnaire (SF-36) over 30 days | Day 1, Day 7, Day 14, Day 21, Day 30 | 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. |
| Change in Profile Mood States (POMS) over 30 days | Day 1, Day 7, Day 14, Day 21, Day 30 | 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). |
| Change in Visual Analog Score (VAS) over 30 days | Day 1, Day 7, Day 14, Day 21, Day 30 | 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) |
| Change in Perceived Recovery Scale (PRS) over 30 days | Day 1, Day 7, Day 14, Day 21, Day 30 | 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) |
Countries
United States
Contacts
CONTACTMichael Michael La Monica, Ph.D., CSCS
CONTACTTim N Ziegenfuss, PhD, CSCS, FISSN
Outcome results
None listed