Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2014-08-31
2014-12-31
Brief Summary
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Detailed Description
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Procedures (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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Mushroom Blend
4 grams daily; oral; 7 and 21 days
Mushroom Blend
Scivation
Placebo
4 grams maltodextrin, oral, 7 and 21 days
Placebo
Interventions
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Mushroom Blend
Scivation
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is able to exercise (i.e. no existing musculoskeletal injury)
* Participant is willing and able to comply with the protocol
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire and physical
* Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days
* Participant agrees to abstain from exercise 24 hours prior to each testing visit
* Participant is not allergic to mushrooms
Exclusion Criteria
* Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders
* Participant is using, or has used one of the following dietary supplements within 12 weeks prior to enrollment: Beta-alanine, Creatine, Carnosine or Taurine
* Participant has lost or gained greater than ten pounds within the previous 3 month
* Participant is currently enrolled in another clinical trial.
* Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)
18 Years
35 Years
ALL
Yes
Sponsors
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Scivation, Inc
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Abbie Smith-Ryan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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Applied Physiology Laboratory, Fetzer Hall
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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14-0062
Identifier Type: -
Identifier Source: org_study_id