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Cognitive Task Sensitivity in Perimenopause and Nutritional Status

Pilot Study Assessing Cognitive Task Sensitivity in Perimenopause and Its Association With Nutritional Status

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07648667
Enrollment
60
Registered
2026-06-15
Start date
2026-06-01
Completion date
2026-07-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function in Perimenopause, Perimenopause

Keywords

Perimenopause, Cognitive Function, Brain Fog, Diet, Nutrition, Food Frequency Questionaire, Menopause Rating Scale

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Northumbria University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Numeric working memory task % accuracyBaselineCognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Numeric working memory task reaction timeBaselineCognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
3-back task % accuracyBaselineCognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
3-back task reaction timeBaselineCognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
3-back task number of false alarmsBaselineCognitive function - working memory task. Measured as number of errors with a lower score indicating better performance.
Corsi blocks task scoreBaselineCognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance
Alphabetic working memory task % accuracyBaselineCognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Alphabetic working memory task reaction timeBaselineCognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Word recognition % accuracyBaselineCognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Word recognition reaction timeBaselineCognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Picture recognition % accuracyBaselineCognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Picture recognition reaction timeBaselineCognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Stroop task % accuracyBaselineCognitive function - selective attention and inhibitory control task. Measured as a percentage, with a higher score indicating better performance
Stroop task reaction timeBaselineCognitive function - selective attention and inhibitory control task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Digit vigilance task % accuracyBaselineCognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Digit vigilance task reaction timeBaselineCognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Digit vigilance number of false alarmsBaselineCognitive function - attention task. Measured as number of errors with a lower score indicating better performance.
Choice reaction time task % accuracyBaselineCognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Choice reaction time task reaction timeBaselineCognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.

Secondary

MeasureTime frameDescription
Menopause symptom severityPast 6 monthsSeverity 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.
Brain fog severityPast 6 monthsSelf-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.

Countries

United Kingdom

Contacts

CONTACTFiona Dodd
f.dodd@northumbria.ac.uk+44 1912273377
PRINCIPAL_INVESTIGATORFiona Dodd

Northumbria University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026