Cognitive Task Sensitivity in Perimenopause and Nutritional Status
12. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
60
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Fiona Dodd
- Telefonnummer: +44 1912273377
- E-Mail: f.dodd@northumbria.ac.uk
Studienorte
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Tyne & Wear
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Newcastle upon Tyne, Tyne & Wear, Vereinigtes Königreich, NE1 8ST
- School of Psychology, Northumbria University
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Kontakt:
- Fiona Dodd
- Telefonnummer: 3377 0191 2273377
- E-Mail: f.dodd@northumbria.ac.uk
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Numeric working memory task % accuracy
Zeitfenster: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
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Numeric working memory task reaction time
Zeitfenster: Baseline
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Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
3-back task % accuracy
Zeitfenster: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
3-back task reaction time
Zeitfenster: 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
Zeitfenster: Baseline
|
Cognitive function - working memory task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
|
|
Corsi blocks task score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Word recognition % accuracy
Zeitfenster: 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
Zeitfenster: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Picture recognition % accuracy
Zeitfenster: Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Picture recognition reaction time
Zeitfenster: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Stroop task % accuracy
Zeitfenster: Baseline
|
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
Zeitfenster: 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
Zeitfenster: Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Digit vigilance task reaction time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Choice reaction time task reaction time
Zeitfenster: Baseline
|
Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Menopause symptom severity
Zeitfenster: 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
Zeitfenster: 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.
|
Past 6 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Fiona Dodd, Northumbria University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
1. Juli 2026
Studienabschluss (Geschätzt)
1. Juli 2026
Studienanmeldedaten
Zuerst eingereicht
8. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Juni 2026
Zuerst gepostet (Tatsächlich)
15. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 12197
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
Fully accessible
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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