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Mushroom Blend on Oxygen Kinetics

3 december 2014 uppdaterad av: University of North Carolina, Chapel Hill

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

28

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • Applied Physiology Laboratory, Fetzer Hall

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 35 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Mushroom Blend
4 grams daily; oral; 7 and 21 days
Scivation
Andra namn:
  • Cordyceps
Placebo-jämförare: Placebo
4 grams maltodextrin, oral, 7 and 21 days

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Oxygen kinetics
Tidsram: 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
Tidsram: during a 3 min
3 min all-out cycling test to measure anaerobic and aerobic performance
during a 3 min

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Lactate
Tidsram: baseline, 2min, 3min, 6min (pre-post supplementation)
baseline, 2min, 3min, 6min (pre-post supplementation)
Cortisol
Tidsram: during a 6 min
during a 6 min
Maximal Oxygen Consumption
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Abbie Smith-Ryan, PhD, University of North Carolina

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2014

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)

1 december 2014

Studieregistreringsdatum

Först inskickad

27 februari 2014

Först inskickad som uppfyllde QC-kriterierna

28 februari 2014

Första postat (Uppskatta)

3 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 december 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 december 2014

Senast verifierad

1 augusti 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 14-0062

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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