[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07729943":3,"trial-entities:NCT07729943":164,"trial-summary:NCT07729943":168},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":53,"secondary_outcomes":70,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":131,"locations":134,"central_contacts":156,"overall_officials":161,"references":162,"see_also_links":163},"NCT07729943","AFS-002-2025CG","A Trial to Study the Effects of Ginseng and Cordyceps on Aerobic Capacity, Lactate Kinetics, and Nitric Oxide","Comparative Effects of Ginseng, Cordyceps, and Placebo on Aerobic Capacity, Lactate Kinetics, and Nitric Oxide Status: A 30-Day Randomized Trial","RECRUITING","2027-02-01","2026-07","2026-07-28","2026-03-15","Applied Food Sciences Inc.","INDUSTRY",false,"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\u002Fnitrites (NOx), circulatory efficiency (oxygen pulse), and lactate kinetics (production and clearance).\n\nComprehensive side effect profile\u002F 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.",null,[19],"Healthy Subjects With Low Energy Levels",[21,22,23,24,25],"Cordyceps (Cordyceps Militaris)","Panax Ginseng","VO2Max","NOx","Circulatory efficiency","INTERVENTIONAL","BASIC_SCIENCE",[29],"NA",{"count":31,"type":32},75,"ESTIMATED",[34,40,48],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DIETARY_SUPPLEMENT","Panax ginseng","Panax Ginseng extract standardized to 5% ginsenosides",[39],"Ginseng",{"type":35,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Cordycep Militaris","Cordycep extract standardized to Cordycepin 0.25% Adenosine 0.15%",[44],"Cordyceps",[46,47],"Cordycep mushroom extract","MycoThrive Cordycep Extract",{"type":49,"name":50,"description":51,"armGroupLabels":52},"OTHER","Placebo","1 gram maltodextrin to mirror 1 gram capsule active",[50],[54,58,62,66],{"measure":55,"description":56,"timeFrame":57},"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","Baseline and Day 30",{"measure":59,"description":60,"timeFrame":61},"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","Baseline Day 1 and then Day 30",{"measure":63,"description":64,"timeFrame":65},"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","Baseline Day 1, then Day 30",{"measure":67,"description":68,"timeFrame":69},"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.","Day 1 and Day 30",[71,75,79,82,86,90,93,96],{"measure":72,"description":73,"timeFrame":74},"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.","Day 1, then at Day 30",{"measure":76,"description":77,"timeFrame":78},"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.","Day 1, then Day 30",{"measure":80,"description":81,"timeFrame":78},"Change in Lactate Kinetics over 30 days","Between and within-group changes in lactate kinetics (production and clearance) measured with a Lactate Plus Meter",{"measure":83,"description":84,"timeFrame":85},"Change in Total Nitrates \u002F Nitrites (NOx) over 30 days","Between and within-group changes in total nitrates\u002Fnitrites (NOx). Total nitrates\u002Fnitrites in serum\u002Fplasma (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).","Day 1 then Day 30",{"measure":87,"description":88,"timeFrame":89},"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.","Day 1, Day 7, Day 14, Day 21, Day 30",{"measure":91,"description":92,"timeFrame":89},"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).",{"measure":94,"description":95,"timeFrame":89},"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)",{"measure":97,"description":98,"timeFrame":89},"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)","ALL","40 Years","65 Years",true,{"inclusion":104,"exclusion":116,"raw_text":130},[105,106,107,108,109,110,111,112,113,114,115],"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 \\\u003C140 mm Hg and diastolic blood pressure \\\u003C 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 (\\\u003C90 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\u002Fwk)",[117,118,119,120,121,122,123,124,125,126,127,128,129],"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\u002FAIDS, etc.).","Medical history of metabolic, cardiovascular, hepatorenal, musculoskeletal, autoimmune, or neurologic disease.","Use of performance enhancing drugs","Anti-inflammatory supplement\u002Fmedication 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\u002Fday).","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","Inclusion Criteria:\n\n* Provide voluntary signed and dated informed consent.\n\n  * Be in good health and able to participate in cognitive performance testing as determined by assessment, medical history, and routine blood chemistries.\n  * Between the of 40 and 65 years of age (inclusive).\n  * Body Mass Index of 18.5-34.9 (inclusive).\n  * Body weight of at least 110 pounds.\n  * Normotensive (seated, resting systolic blood pressure \\\u003C140 mm Hg and diastolic blood pressure \\\u003C 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.\n  * Normal supine, resting heart rate (\\\u003C90 per minute).\n  * Able to provide an adequate blood draw.\n  * 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.\n  * 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.\n  * Recreationally active (≥3 exercise sessions\u002Fwk)\n\nExclusion Criteria:\n\n-Smokers.\n\n* History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).\n* Prior gastrointestinal bypass surgery (Lapband, etc.).\n* 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).\n* Chronic medically diagnosed inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV\u002FAIDS, etc.).\n* Medical history of metabolic, cardiovascular, hepatorenal, musculoskeletal, autoimmune, or neurologic disease.\n* Use of performance enhancing drugs\n* Anti-inflammatory supplement\u002Fmedication use started within 4 weeks\n* Ergogenic supplement use started within 4 weeks. (i.e. beta-alanine, creatine, beet root, citrulline, arginine, )\n* Individuals with excessive caffeine intake (\\>400mg\u002Fday).\n* Known sensitivity to any ingredient in the test formulations as listed in the Certificates- of-Analysis.\n* Women currently pregnant, trying to become pregnant or breastfeeding a child.\n* 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",[132,133],"ADULT","OLDER_ADULT",[135],{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":140,"contacts":141,"geoPoint":153},"The Center for Applied Health Sciences","Canfield","Ohio","44406","United States",[142,147,150],{"name":143,"role":144,"phone":145,"email":146},"Jennifer Sandrock, MS RD, CCRC","CONTACT","330.926.6927","jh@appliedhealthsciences.org",{"name":148,"role":144,"phone":145,"email":149},"Tim N Ziegenfuss, PhD, CSCS, FISSN","tz@appliedhealthsciences.org",{"name":151,"role":152},"Michael La Monica, Ph.D., CSCS","PRINCIPAL_INVESTIGATOR",{"lat":154,"lon":155},41.02506,-80.76091,[157,160],{"name":158,"role":144,"phone":145,"email":159},"Michael Michael La Monica, Ph.D., CSCS","ml@appliedhealthsciences.org",{"name":148,"role":144,"phone":145,"email":149},[],[],[],{"nct_id":4,"conditions":165,"biomarkers":167},[166],"Healthy Volunteers",[],{"nct_id":4,"found":102,"summary":169,"prompt_version":179},{"design":170,"status":171,"heading":172,"summary":173,"follow_up":174,"word_count":175,"commitments":176,"compensation":177,"drugs_mentioned":178},"This is a double-blind, randomized, parallel group, three-arm, placebo-controlled study involving 75 participants.","completed","Study of Ginseng and Cordyceps for Low Energy Levels","This study is looking for healthy adults aged 40-65 who experience low energy. It aims to see if taking Panax ginseng or Cordycep Militaris supplements for four weeks can improve your aerobic capacity (how well your body uses oxygen during exercise), lactate kinetics (how your body handles lactic acid), and circulatory efficiency (how well your heart pumps blood). You would be randomly assigned to receive either ginseng, cordyceps, or a placebo (an inactive substance like a sugar pill). Researchers will measure these effects by comparing your results at the beginning of the study to your results after 30 days.","Your progress will be measured at baseline and again after 30 days of treatment.",99,"You would attend 3 study visits over 30 days. These visits include screening, medical history, blood work, and cognitive performance testing.","Not stated in the trial record.",[36,41,50],"v2"]