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Cognitive Task Sensitivity in Perimenopause and Nutritional Status

12 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

60

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Royaume-Uni
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, Royaume-Uni, NE1 8ST
        • School of Psychology, Northumbria University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Numeric working memory task % accuracy
Délai: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
Numeric working memory task reaction time
Délai: Baseline
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
3-back task % accuracy
Délai: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
3-back task reaction time
Délai: Baseline
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
3-back task number of false alarms
Délai: Baseline
Cognitive function - working memory task. Measured as number of errors with a lower score indicating better performance.
Baseline
Corsi blocks task score
Délai: Baseline
Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance
Baseline
Alphabetic working memory task % accuracy
Délai: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
Alphabetic working memory task reaction time
Délai: Baseline
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Word recognition % accuracy
Délai: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Baseline
Word recognition reaction time
Délai: Baseline
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Picture recognition % accuracy
Délai: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Baseline
Picture recognition reaction time
Délai: Baseline
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Stroop task % accuracy
Délai: Baseline
Cognitive function - selective attention and inhibitory control task. Measured as a percentage, with a higher score indicating better performance
Baseline
Stroop task reaction time
Délai: Baseline
Cognitive function - selective attention and inhibitory control task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Digit vigilance task % accuracy
Délai: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Baseline
Digit vigilance task reaction time
Délai: Baseline
Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Digit vigilance number of false alarms
Délai: Baseline
Cognitive function - attention task. Measured as number of errors with a lower score indicating better performance.
Baseline
Choice reaction time task % accuracy
Délai: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Baseline
Choice reaction time task reaction time
Délai: Baseline
Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Menopause symptom severity
Délai: Past 6 months
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.
Past 6 months
Brain fog severity
Délai: Past 6 months
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.
Past 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Northumbria University

Les enquêteurs

  • Chercheur principal: Fiona Dodd, Northumbria University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juillet 2026

Achèvement de l'étude (Estimé)

1 juillet 2026

Dates d'inscription aux études

Première soumission

8 juin 2026

Première soumission répondant aux critères de contrôle qualité

12 juin 2026

Première publication (Réel)

15 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 12197

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage 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.

Critères d'accès au partage IPD

Fully accessible

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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