- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02075892
Mushroom Blend on Oxygen Kinetics
Acute Effects of a Mushroom Blend on Oxygen Kinetics, Aerobic Power and Time to Fatigue
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Applied Physiology Laboratory, Fetzer Hall
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Mushroom Blend
4 grams daily; oral; 7 and 21 days
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Scivation
Otros nombres:
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Comparador de placebos: Placebo
4 grams maltodextrin, oral, 7 and 21 days
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Oxygen kinetics
Periodo de tiempo: 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
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lactate
Periodo de tiempo: baseline, 2min, 3min, 6min (pre-post supplementation)
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baseline, 2min, 3min, 6min (pre-post supplementation)
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Cortisol
Periodo de tiempo: during a 6 min
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during a 6 min
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Maximal Oxygen Consumption
Periodo de tiempo: during a graded exercise test to exhaustion
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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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Abbie Smith-Ryan, PhD, University of North Carolina
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 14-0062
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