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Completed

NCT Number: NCT02075892

Mushroom Blend on Oxygen Kinetics

Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics, aerobic power and time to fatigue in healthy adults.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory, Fetzer Hall

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mushroom blend

Dietary Supplement

Scivation

Other names: Cordyceps

Placebo

Dietary Supplement

Primary outcomes

  1. Oxygen kinetics

    Time frame: during a 6 min

    oxygen uptake and utilization using indirect calorimetry during a 6 min steady-state exercise bout

  2. Critical Power

    Time frame: during a 3 min

    3 min all-out cycling test to measure anaerobic and aerobic performance

Secondary outcomes

  1. Lactate

    Time frame: baseline, 2min, 3min, 6min (pre-post supplementation)

  2. Cortisol

    Time frame: during a 6 min

  3. Maximal Oxygen Consumption

    Time frame: during a graded exercise test to exhaustion

    oxygen consumption and utilization using indirect calorimetry during a graded exercise test

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Scivation, Inc

Registry information

Official study title

Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2014
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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