- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02075892
Mushroom Blend on Oxygen Kinetics
Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599
- Applied Physiology Laboratory, Fetzer Hall
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Mushroom Blend
4 grams daily; oral; 7 and 21 days
|
Scivation
Andere Namen:
|
|
Placebo-Komparator: Placebo
4 grams maltodextrin, oral, 7 and 21 days
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Oxygen kinetics
Zeitfenster: during a 6 min
|
oxygen uptake and utilization using indirect calorimetry during a 6 min steady-state exercise bout
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during a 6 min
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Critical Power
Zeitfenster: during a 3 min
|
3 min all-out cycling test to measure anaerobic and aerobic performance
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during a 3 min
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Lactate
Zeitfenster: baseline, 2min, 3min, 6min (pre-post supplementation)
|
baseline, 2min, 3min, 6min (pre-post supplementation)
|
|
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Cortisol
Zeitfenster: during a 6 min
|
during a 6 min
|
|
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Maximal Oxygen Consumption
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Abbie Smith-Ryan, PhD, University of North Carolina
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 14-0062
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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