Oxygen UtilizationNCT02075892
Mushroom Blend on Oxygen Kinetics
A study testing Mushroom Blend in people with Oxygen Utilization and Oxygen Kinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics, aerobic power and time to fatigue in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Utilization, Oxygen Kinetics
- What is being tested?
- Mushroom Blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory, Fetzer Hall
Chapel Hill, North Carolina, 27599
About this study
Official title: Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue
Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics, aerobic power and time to fatigue in healthy adults.
Read the 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.
- Conditions
- Oxygen Utilization, Oxygen Kinetics
- Being tested
- Mushroom Blend, Placebo
- Keywords
- cordyceps, aerobic capacity, exercise performance, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mushroom BlendDietary supplement
Also called Cordyceps
Scivation
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Mushroom Blend | Active comparator | 4 grams daily; oral; 7 and 21 days Receives: Dietary Supplement: Mushroom Blend |
| Placebo | Placebo comparator | 4 grams maltodextrin, oral, 7 and 21 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen kinetics
oxygen uptake and utilization using indirect calorimetry during a 6 min steady-state exercise bout
Measured: during a 6 min
Critical Power
3 min all-out cycling test to measure anaerobic and aerobic performance
Measured: during a 3 min
Secondary outcomes (3)
Lactate
Measured: baseline, 2min, 3min, 6min (pre-post supplementation)
Cortisol
Measured: during a 6 min
Maximal Oxygen Consumption
oxygen consumption and utilization using indirect calorimetry during a graded exercise test
Measured: during a graded exercise test to exhaustion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen UtilizationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Scivation, Inc
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075892
- Sponsor's protocol ID
- 14-0062
- Status last verified
- Aug 2014
- First submitted
- 27 Feb 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue
- ClinicalTrials.gov ID
- NCT02075892
- Acronym / sponsor ID
- 14-0062
- Conditions
- Oxygen Utilization, Oxygen Kinetics
- Keywords
- cordyceps, aerobic capacity, exercise performance, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Scivation, Inc
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics, aerobic power and time to fatigue in healthy adults.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mushroom Blend | Active comparator | Dietary Supplement: Mushroom Blend4 grams daily; oral; 7 and 21 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 grams maltodextrin, oral, 7 and 21 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mushroom BlendAlso: CordycepsScivation | Dietary supplement | Mushroom Blend |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Oxygen kinetics
Time frame: during a 6 min
oxygen uptake and utilization using indirect calorimetry during a 6 min steady-state exercise bout
Critical Power
Time frame: during a 3 min
3 min all-out cycling test to measure anaerobic and aerobic performance
3 secondary outcomes
Lactate
Time frame: baseline, 2min, 3min, 6min (pre-post supplementation)
Cortisol
Time frame: during a 6 min
Maximal Oxygen Consumption
Time frame: during a graded exercise test to exhaustion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbie Smith-Ryan, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mushroom Blend in people with Oxygen Utilization and Oxygen Kinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen kinetics (time frame: during a 6 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.