- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03870126
Dose Effect of a Plant Extract on Fatigue
14 de enero de 2020 actualizado por: PepsiCo Global R&D
Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue
Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
28
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Georgia
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Athens, Georgia, Estados Unidos, 30602
- University of Georgia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 49 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 18-49 years of age
- Self-report of good health
- Physical activity requirement: Recreationally active (exercise ≥3 times per week for >30 minutes per session; both cyclists and non-cyclists may enroll)
Exclusion Criteria:
- Under the care of a physician
- Visual impairment that cannot be corrected with glasses or contact lenses
- Inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the Borg 6 to 20 scale. High intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.)
- Inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or >50% incorrect responses)
- Presence of current or chronic gastrointestinal, sleep or psychiatric disorder
- Pregnant/lactating
- Current smoker
- Report illegal drug use
- Report hypersensitivity to caffeine
- Food allergies/intolerances/sensitivities (including coffee or related foods/beverages/products)
- Current use of dietary supplements, or prescription medication except for oral contraceptives
- Unwillingness to abstain from over the counter medications (e.g. NSAIDS, allergy medications) and caffeine/coffee/foods high in polyphenols for 12 hours prior to the study
- Unwilling to refrain from consuming apple and grapefruit products on study days and 12 hours prior to test days.
- Participation in another clinical trial within the past 30 days or participation in another PepsiCo trial in the past 6 months
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Flavored Beverage Mix 1
Flavored still beverage
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Consume one beverage at the beginning of each visit of the cross-over sequence
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Experimental: Flavored Beverage Mix 2
Flavored still beverage with polyphenols, concentration 1
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Consume one beverage at the beginning of each visit of the cross-over sequence
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Experimental: Flavored Beverage Mix 3
Flavored still beverage with polyphenols, concentration 2
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Consume one beverage at the beginning of each visit of the cross-over sequence
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Experimental: Flavored Beverage Mix 4
Flavored still beverage with caffeine
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Consume one beverage at the beginning of each visit of the cross-over sequence
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Subjective mental energy: Cognitive test battery
Periodo de tiempo: Baseline and 60 min post treatment
|
Changes in subjective measures of mental alertness and mental fatigue through computer administered cognitive test battery domains of short-term memory, attention and mood.
Tasks are word presentation, word recognition, picture presentation, picture recognition, Cognitive Demand Battery (CDB) serial 3 and serial 7 subtraction, and Bakan task/Rapid Visual Information Processing (RVIP).
Performance measures: % correct, % errors and response time in milliseconds.
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for mental alertness
Periodo de tiempo: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for mental alertness has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for motivation
Periodo de tiempo: Baseline and 60 min post treatment
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Changes in subjective ratings of motivation following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for motivation has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for mental fatigue
Periodo de tiempo: Baseline and 60 min post treatment
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Changes in subjective ratings of fatigue following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for fatigue has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
Periodo de tiempo: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
Mental and Physical State and Trait Energy and Fatigue Scales (EFS State Scales) consist of 12 VAS items to measure intensity of current feeling of physical energy and fatigue and mental energy and fatigue (3 sub-scales each).
Score range: The 3 items from each sub-scale are summed and scores for each sub-scale range from 0-300 (none to strongest).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for mood
Periodo de tiempo: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
The Bond-Lader test uses 16 Visual Analog Scales (VAS) to measure different aspects of mood, with score range 0-100 for each scale (from absence of feeling to presence of feeling).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for caffeine symptoms
Periodo de tiempo: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
Caffeine symptoms are measured on paper using 8 Visual Analog Scales (VAS) with score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Physical performance
Periodo de tiempo: During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
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Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.
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During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
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Physical Fatigue
Periodo de tiempo: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Alertness
Periodo de tiempo: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Effort
Periodo de tiempo: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, Borg Ratings of Perceived Exertion (RPE) measures perception of effort, score range 6-20.
Higher score indicates greater effort.
17 or greater generally indicates maximal effort
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Quadriceps muscle pain
Periodo de tiempo: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale with ratio-like properties, scale 0-10 with open-ended option for ratings greater than but proportional to 10. Higher scores indicate greater perception of pain in the quadriceps
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Patrick J O'Connor, PhD, University of Georgia
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de enero de 2019
Finalización primaria (Actual)
6 de diciembre de 2019
Finalización del estudio (Actual)
6 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
26 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
8 de marzo de 2019
Publicado por primera vez (Actual)
11 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
14 de enero de 2020
Última verificación
1 de enero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PEP-1807
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
IPD will be kept securely at U. Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu)
Marco de tiempo para compartir IPD
After publication
Criterios de acceso compartido de IPD
Open access, upon request
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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