- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02075892
Mushroom Blend on Oxygen Kinetics
Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- Applied Physiology Laboratory, Fetzer Hall
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Mushroom Blend
4 grams daily; oral; 7 and 21 days
|
Scivation
Ostatní jména:
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Komparátor placeba: Placebo
4 grams maltodextrin, oral, 7 and 21 days
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Oxygen kinetics
Časové okno: during a 6 min
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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
Časové okno: during a 3 min
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3 min all-out cycling test to measure anaerobic and aerobic performance
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during a 3 min
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Lactate
Časové okno: baseline, 2min, 3min, 6min (pre-post supplementation)
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baseline, 2min, 3min, 6min (pre-post supplementation)
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|
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Cortisol
Časové okno: during a 6 min
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during a 6 min
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Maximal Oxygen Consumption
Časové okno: during a graded exercise test to exhaustion
|
oxygen consumption and utilization using indirect calorimetry during a graded exercise test
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during a graded exercise test to exhaustion
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Abbie Smith-Ryan, PhD, University of North Carolina
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 14-0062
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