- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075892
Mushroom Blend on Oxygen Kinetics
Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants: Twenty-eight, healthy, active, recreationally-trained adults ages 18-35.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Applied Physiology Laboratory, Fetzer Hall
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant has been involved in exercise program for a minimum of one year prior to recruitment (≥ 3 d/wk)
- 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:
- Participant has a BMI ≤ 28 kg/m² (pre-screening inclusion)
- 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)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mushroom Blend
4 grams daily; oral; 7 and 21 days
|
Scivation
Other Names:
|
|
Placebo Comparator: Placebo
4 grams maltodextrin, oral, 7 and 21 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen kinetics
Time Frame: during a 6 min
|
oxygen uptake and utilization using indirect calorimetry during a 6 min steady-state exercise bout
|
during a 6 min
|
|
Critical Power
Time Frame: during a 3 min
|
3 min all-out cycling test to measure anaerobic and aerobic performance
|
during a 3 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactate
Time Frame: baseline, 2min, 3min, 6min (pre-post supplementation)
|
baseline, 2min, 3min, 6min (pre-post supplementation)
|
|
|
Cortisol
Time Frame: during a 6 min
|
during a 6 min
|
|
|
Maximal Oxygen Consumption
Time Frame: during a graded exercise test to exhaustion
|
oxygen consumption and utilization using indirect calorimetry during a graded exercise test
|
during a graded exercise test to exhaustion
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Abbie Smith-Ryan, PhD, University of North Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14-0062
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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