Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
Study NCT ID:
NCT02075892
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2014-02-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mushroom Blend on Oxygen Kinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen kinetics', 'timeFrame': 'during a 6 min', 'description': 'oxygen uptake and utilization using indirect calorimetry during a 6 min steady-state exercise bout'}, {'measure': 'Critical Power', 'timeFrame': 'during a 3 min', 'description': '3 min all-out cycling test to measure anaerobic and aerobic performance'}], 'secondaryOutcomes': [{'measure': 'Lactate', 'timeFrame': 'baseline, 2min, 3min, 6min (pre-post supplementation)'}, {'measure': 'Cortisol', 'timeFrame': 'during a 6 min'}, {'measure': 'Maximal Oxygen Consumption', 'timeFrame': 'during a graded exercise test to exhaustion', 'description': 'oxygen consumption and utilization using indirect calorimetry during a graded exercise test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cordyceps, aerobic capacity, exercise performance, fatigue'], 'conditions': ['Oxygen Utilization', 'Oxygen Kinetics']}, 'descriptionModule': {'briefSummary': 'Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics, aerobic power and time to fatigue in healthy adults.', 'detailedDescription': 'Participants: Twenty-eight, healthy, active, recreationally-trained adults ages 18-35.\n\nProcedures (methods): All subjects will report to the Applied Physiology Laboratory in Fetzer Rm 025 for phase I of the study for a total of 7 visits. A randomly selected subset of 8 participants will continue to phase II, and return to the lab for an additional 3 visits to evaluate feasibility. Visit 1 will consist of a physical, enrollment and consenting. Visits, 2, 3, and 4 will be separated by a minimum of 24 hours. During visit 2, participants will perform a maximal oxygen consumption (VO2max) test on a cycle ergometer. During visit 3 participants will be asked to complete a 6-minute oxygen kinetics test on a cycle ergometer; lactate threshold and oxygen saturation will be measured at baseline, minutes 2, 3 and 6 during the 6 min ride. During visit 4, participants will perform a 3-minute critical power (CP) test and will provide a saliva sample, to be measured for cortisol levels, immediately prior to and after the CP test. Following visit 4, participants will be randomly assigned, in a double-blind fashion, to either a placebo or mushroom blend treatment group. Participants in the placebo and treatment groups will be asked to consume 2 servings, 3 times daily for 7 days. Following supplementation, participants will return to the laboratory for visits 5-7, each of which will be separated by a minimum of 24 hours. The same protocol performed during visits 2-4 will be repeated in the same order for visits 5-7; the VO 2max test, the 6 min oxygen kinetics test, and the CP test with a pre and post saliva sample. The randomly selected subset of 8 participants will continue into phase II (n=4 for treatment; n=4 for placebo). During phase II, the 8 participants in the placebo and treatment groups will be asked to consume 2 servings, 3 times daily for 14 additional days to determine feasibility of a longer supplementation phase. Following supplementation, the same protocol performed during visits 2-4 will be repeated in the same order for visits 8-10, each of which will be separated by a minimum of 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has been involved in exercise program for a minimum of one year prior to recruitment (≥ 3 d/wk)\n* Participant is able to exercise (i.e. no existing musculoskeletal injury)\n* Participant is willing and able to comply with the protocol\n* Participant is apparently healthy and free from disease, as determined by a health history questionnaire and physical\n* Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days\n* Participant agrees to abstain from exercise 24 hours prior to each testing visit\n* Participant is not allergic to mushrooms\n\nExclusion Criteria:\n\n* Participant has a BMI ≤ 28 kg/m² (pre-screening inclusion)\n* Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders\n* Participant is using, or has used one of the following dietary supplements within 12 weeks prior to enrollment: Beta-alanine, Creatine, Carnosine or Taurine\n* Participant has lost or gained greater than ten pounds within the previous 3 month\n* Participant is currently enrolled in another clinical trial.\n* Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)'}, 'identificationModule': {'nctId': 'NCT02075892', 'briefTitle': 'Mushroom Blend on Oxygen Kinetics', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue', 'orgStudyIdInfo': {'id': '14-0062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mushroom Blend', 'description': '4 grams daily; oral; 7 and 21 days', 'interventionNames': ['Dietary Supplement: Mushroom Blend']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '4 grams maltodextrin, oral, 7 and 21 days', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Mushroom Blend', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cordyceps'], 'description': 'Scivation', 'armGroupLabels': ['Mushroom Blend']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Applied Physiology Laboratory, Fetzer Hall', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Abbie Smith-Ryan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scivation, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}