Hypo-hydration Mood and Cognition
10 de mayo de 2019 actualizado por: David Benton, Swansea University
Hypo-hydration, Mood and Cognition: the Effect of the Colour and Type of Drink
Recently changes in mood and cognition have been reported following minor reductions in hydration status.
The aim is to explore that such changes in part at least reflect placebo response; therefore the consumption of plain or coloured water will be compared in drinks designed to differ in their ability to rehydrate.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
162 individuals will be subject to a temperature of 30°C for three hours, and mood and cognition monitored.
Randomly on two occasions they will consume no drink or 300ml of plain or red colored water.
In addition they will take a capsule containing sodium chloride or a placebo.
Mood will be monitored using visual analogue scales and a battery of cognitive tests will be completed on three occasions: attention, episodic and working memory, reactions times.
Urine osmolality will be measured at the beginning and end of the study and changes in body mass will be recorded.
Changes in functioning will be related to the nature of the drink and changes in osmolality and body mass.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
162
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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Wales
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Swansea, Wales, Reino Unido, sa2 8pp
- Reclutamiento
- Psychology, Swansea University
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Swansea, Wales, Reino Unido, SA2 8PP
- Reclutamiento
- Swansea University
-
Contacto:
- David Benton, DSc
- Número de teléfono: ++44 1792 295607
- Correo electrónico: d.benton@swansea.ac.uk
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Contacto:
- Sara Long, B.Sc.
- Número de teléfono: ++44 1792 295278
- Correo electrónico: 444451@swansea.ac.uk
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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 30 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria:
- 18 to 30 years
- Non-smokers
- BMI < 30
- By self-report in good health
- Not taking medication for any psychological or other health disorder.
Exclusion Criteria:
- Do not meet inclusion criteria
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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Sodium chloride / Water
300mg sodium chloride consumed in a capsule on two occasions with 300ml water
|
Drinks with and without a salt containing capsule
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Comparador activo: Sodium chloride / no water
300 mg sodium chloride consumed
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Drinks with and without a salt containing capsule
|
|
Comparador activo: Sodium chloride / colored water
300mg sodium chloride consumed in a capsule on two occasions with 300ml coloured water
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Drinks with and without a salt containing capsule
|
|
Comparador de placebos: Placebo / water
Placebo consumed in a capsule on two occasions with 300ml water
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Drinks with and without a salt containing capsule
|
|
Comparador de placebos: Placebo / no water
Placebo capsule consumed
|
Drinks with and without a salt containing capsule
|
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Comparador de placebos: Placebo / coloured water
Placebo consumed in a capsule on two occasions with 300ml colored water
|
Drinks with and without a salt containing capsule
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mood rating: agreeable / hostile
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words agreeable/hostile and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
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Changes from baseline after 90 and 180 minutes
|
|
Mood rating: confused / clearheaded
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words confused / clearheaded and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
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Changes from baseline after 90 and 180 minutes
|
|
Mood rating: composed / anxious
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words composed / anxious and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
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Changes from baseline after 90 and 180 minutes
|
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Mood rating: depressed / elated
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words depressed / elated and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
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Changes from baseline after 90 and 180 minutes
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Mood rating: tired / energetic
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words tired / energetic and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
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Changes from baseline after 90 and 180 minutes
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Mood rating: confident / unsure
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words confident / unsure and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
|
Changes from baseline after 90 and 180 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Episodic memory
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
|
A list of 30 words will be presented after which the subject writes down as many as can be recalled.
The resulting score will vary from 0-30.
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Changes from baseline after 90 and 180 minutes
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Serial Sevens; test of working memory
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
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28 numbers each of three digits will be presented and the subject indicates whether a subsequent number was exactly seven less.
The measure reported is the response time in milli-seconds taken to respond
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Changes from baseline after 90 and 180 minutes
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Attention: Arrow Flankers
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
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A series is presented that can be >>>>> or >><>> and the subject has to indicated whether the middle symbol points to the right or left.
The measure reported is the time taken to respond in milli-seconds
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Changes from baseline after 90 and 180 minutes
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Reaction times
Periodo de tiempo: Changes from baseline after 90 and 180 minutes
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The time to press a button under an illuminated light was recorded in milli-seconds when there was 1, 2, 4, or 8 possible lamps that could be lit.
20 trials were performed with each of the four number of lights.
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Changes from baseline after 90 and 180 minutes
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: David Benton, DSc, Professor of Psychology
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)
1 de enero de 2018
Finalización primaria (Anticipado)
31 de julio de 2019
Finalización del estudio (Anticipado)
31 de julio de 2019
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
10 de mayo de 2019
Publicado por primera vez (Actual)
13 de mayo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
10 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- DB-0519
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .