Cognitive Task Sensitivity in Perimenopause and Nutritional Status
12. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fiona Dodd
- Telefonnummer: +44 1912273377
- E-mail: f.dodd@northumbria.ac.uk
Studiesteder
-
-
Tyne & Wear
-
Newcastle upon Tyne, Tyne & Wear, Det Forenede Kongerige, NE1 8ST
- School of Psychology, Northumbria University
-
Kontakt:
- Fiona Dodd
- Telefonnummer: 3377 0191 2273377
- E-mail: f.dodd@northumbria.ac.uk
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric working memory task % accuracy
Tidsramme: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Numeric working memory task reaction time
Tidsramme: 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
Tidsramme: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
3-back task reaction time
Tidsramme: 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
Tidsramme: Baseline
|
Cognitive function - working memory task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
|
|
Corsi blocks task score
Tidsramme: 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
Tidsramme: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Alphabetic working memory task reaction time
Tidsramme: Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Word recognition % accuracy
Tidsramme: Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Word recognition reaction time
Tidsramme: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Picture recognition % accuracy
Tidsramme: Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Picture recognition reaction time
Tidsramme: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Stroop task % accuracy
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Digit vigilance task reaction time
Tidsramme: 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
Tidsramme: Baseline
|
Cognitive function - attention task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
|
|
Choice reaction time task % accuracy
Tidsramme: Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Choice reaction time task reaction time
Tidsramme: Baseline
|
Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Menopause symptom severity
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Fiona Dodd, Northumbria University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juli 2026
Studieafslutning (Anslået)
1. juli 2026
Datoer for studieregistrering
Først indsendt
8. juni 2026
Først indsendt, der opfyldte QC-kriterier
12. juni 2026
Først opslået (Faktiske)
15. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12197
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
Fully accessible
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .