Cognitive Task Sensitivity in Perimenopause and Nutritional Status
12 de junio de 2026 actualizado por: Northumbria University
Pilot Study Assessing Cognitive Task Sensitivity in Perimenopause and Its Association With Nutritional Status
Perimenopause is when you have symptoms of menopause but your periods have not stopped.
Brain-related changes are just one of the many symptoms that occur, and changes to memory and concentration ("brain fog") are frequently reported to be a challenge to those experiencing them.
Diet is also understood to play an important role during menopause, however there is still more to learn about the direct impact of nutrition on brain-related symptoms associated with perimenopause.
The aim of this research is to identify mental tasks capable of capturing perimenopause-related changes and to better understand how diet might account for differences in mental task performance.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
The study will employ a cross-sectional design. Sixty participants will be recruited (30 participants will be recruited who report being severely affected by cognition-related/brain fog symptoms and 30 participants will be recruited who do not report being severely affected).
Interested participants will follow a link to the study information and consent and will then answer the eligibility questions, including questions about medication/supplementation. Participants are directed to contact the researchers before continuing should any of their answers suggest they may not be eligible to participate. Demographic data will be collected and participants will then complete the Menopause Rating Scale (MRS), followed by the Brain Fog Scale (BFS) and a question asking specifically about how much they are currently affected by brain fog as a result of perimenopause. They will also complete a shortened version of the Adapted Muscle-Strengthening Exercise Questionnaire (A-MSEQ).
Following this participants will be auto directed by a separate link to Cognimapp (a web-based platform for cognitive and mood assessments that can be accessed via a mobile device) where they will complete a brief training session, after which they will complete a full run through of the cognitive tasks.
Once the cognitive tasks have been completed participants will be redirected to a second Qualtrics survey to complete the food frequency questionnaire (EPIC FFQ). Participants will then receive an online debrief and be redirected to a final questionnaire to capture their email address so that they may be compensated £20.
Tipo de estudio
De observación
Inscripción (Estimado)
60
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.
Estudio Contacto
- Nombre: Fiona Dodd
- Número de teléfono: +44 1912273377
- Correo electrónico: f.dodd@northumbria.ac.uk
Ubicaciones de estudio
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Tyne & Wear
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Newcastle upon Tyne, Tyne & Wear, Reino Unido, NE1 8ST
- School of Psychology, Northumbria University
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Contacto:
- Fiona Dodd
- Número de teléfono: 3377 0191 2273377
- Correo electrónico: f.dodd@northumbria.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
- Adulto
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Perimenopausal women aged 40-55 years who report being severely affected by cognitive symptoms/brain fog and those who do not report being severely affected.
Descripción
Inclusion Criteria:
- Aged 40-55 years
- Self-assess as healthy
- Experienced troublesome perimenopause symptoms for at least the past 6 months (as assessed by the Menopause Rating Scale)
- Not post-menopause (defined as 12 months with no periods)
- Non-smoker (including vaping)
- Not lactating or pregnant (or seeking pregnancy)
- Oral contraception and hormone replacement therapy allowed if taken for at least 3 months prior
- Cognitive symptoms/brain fog are not required for participation
Exclusion Criteria:
- Post-menopause (12 months with no periods)
- Medically induced perimenopause symptoms
- Antidepressant/antianxiety medication or other medication likely to affect cognition in the past 6 months
- Receiving gender-affirming hormone therapy
- Nutritional supplementation (apart from vitamin D) within the last month (more than 3 consecutive days or 4 total)
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
Cohortes e Intervenciones
Grupo / Cohorte |
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Perimenopausal women who report being severely affected by cognition-related/brain fog symptoms
30 perimenopausal women aged 40-55 who report being severely affected by cognition-related/brain fog symptoms
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Perimenopausal women who do not report being severely affected by cog-related/brain fog symptoms
30 perimenopausal women aged 40-55 who do not report being severely affected by cognition-related symptoms/brain fog.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Numeric working memory task % accuracy
Periodo de tiempo: Baseline
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Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
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Baseline
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Numeric working memory task reaction time
Periodo de tiempo: Baseline
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Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
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Baseline
|
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3-back task % accuracy
Periodo de tiempo: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
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3-back task reaction time
Periodo de tiempo: Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
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3-back task number of false alarms
Periodo de tiempo: Baseline
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Cognitive function - working memory task.
Measured as number of errors with a lower score indicating better performance.
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Baseline
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Corsi blocks task score
Periodo de tiempo: Baseline
|
Cognitive function - working memory task.
Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance
|
Baseline
|
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Alphabetic working memory task % accuracy
Periodo de tiempo: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
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Alphabetic working memory task reaction time
Periodo de tiempo: Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Word recognition % accuracy
Periodo de tiempo: Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
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Word recognition reaction time
Periodo de tiempo: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
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Picture recognition % accuracy
Periodo de tiempo: Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
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Picture recognition reaction time
Periodo de tiempo: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
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Stroop task % accuracy
Periodo de tiempo: Baseline
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Cognitive function - selective attention and inhibitory control task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
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Stroop task reaction time
Periodo de tiempo: Baseline
|
Cognitive function - selective attention and inhibitory control task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
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Digit vigilance task % accuracy
Periodo de tiempo: Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
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Digit vigilance task reaction time
Periodo de tiempo: Baseline
|
Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
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Digit vigilance number of false alarms
Periodo de tiempo: Baseline
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Cognitive function - attention task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
|
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Choice reaction time task % accuracy
Periodo de tiempo: Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
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Choice reaction time task reaction time
Periodo de tiempo: Baseline
|
Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Menopause symptom severity
Periodo de tiempo: Past 6 months
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Severity of somatic, psychological and urogenital symptoms assessed using the Menopause Rating Scale (MRS; Hauser et al., 1994), an 11-item questionnaire rated on a 5-point Likert scale.
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Past 6 months
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Brain fog severity
Periodo de tiempo: Past 6 months
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Self-reported brain fog assessed using the Brain Fog Scale (BFS; Debowska et al., 2024), a 23-item questionnaire rated on a 5-point Likert scale.
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Past 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Fiona Dodd, Northumbria University
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 (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de julio de 2026
Finalización del estudio (Estimado)
1 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12197
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
An anonymised dataset will be shared on this platform within the results section.
Any information which may identify individual participants will be removed from the dataset before it is shared.
Data will be shared in accordance with FAIR (findable, accessible, interoperable, reusable) principles.
Participants will consent to the data being shared in this way.
Marco de tiempo para compartir IPD
Data will be available 3 months after article publication and the data will be made accessible for up to 24 months.
Extensions will be considered on a case-by-case basis.
Criterios de acceso compartido de IPD
Fully accessible
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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. .