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Cognitive Task Sensitivity in Perimenopause and Nutritional Status

12 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

60

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Storbritannien
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, Storbritannien, NE1 8ST
        • School of Psychology, Northumbria University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Numeric working memory task % accuracy
Tidsram: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
Numeric working memory task reaction time
Tidsram: 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
Tidsram: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
3-back task reaction time
Tidsram: 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
Tidsram: Baseline
Cognitive function - working memory task. Measured as number of errors with a lower score indicating better performance.
Baseline
Corsi blocks task score
Tidsram: 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
Tidsram: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
Alphabetic working memory task reaction time
Tidsram: Baseline
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Word recognition % accuracy
Tidsram: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Baseline
Word recognition reaction time
Tidsram: Baseline
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Picture recognition % accuracy
Tidsram: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Baseline
Picture recognition reaction time
Tidsram: Baseline
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Stroop task % accuracy
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Baseline
Digit vigilance task reaction time
Tidsram: 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
Tidsram: Baseline
Cognitive function - attention task. Measured as number of errors with a lower score indicating better performance.
Baseline
Choice reaction time task % accuracy
Tidsram: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Baseline
Choice reaction time task reaction time
Tidsram: Baseline
Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Menopause symptom severity
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Northumbria University

Utredare

  • Huvudutredare: Fiona Dodd, Northumbria University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 juli 2026

Avslutad studie (Beräknad)

1 juli 2026

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 12197

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

Fully accessible

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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