Cognitive Task Sensitivity in Perimenopause and Nutritional Status
Pilot Study Assessing Cognitive Task Sensitivity in Perimenopause and Its Association With Nutritional Status
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
June 15, 2026
June 1, 2026
1 month
June 8, 2026
June 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
Numeric working memory task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
Numeric working memory task reaction time
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
3-back task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
3-back task reaction time
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
Cognitive function - working memory task. Measured as number of errors with a lower score indicating better performance.
Baseline
Corsi blocks task score
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
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Baseline
Alphabetic working memory task reaction time
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Word recognition % accuracy
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Baseline
Word recognition reaction time
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Picture recognition % accuracy
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Baseline
Picture recognition reaction time
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Stroop task % accuracy
Cognitive function - selective attention and inhibitory control task. Measured as a percentage, with a higher score indicating better performance
Baseline
Stroop task reaction time
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
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Baseline
Digit vigilance task reaction time
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
Cognitive function - attention task. Measured as number of errors with a lower score indicating better performance.
Baseline
Choice reaction time task % accuracy
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Baseline
Choice reaction time task reaction time
Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Baseline
Secondary Outcomes (2)
Menopause symptom severity
Past 6 months
Brain fog severity
Past 6 months
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Psychology, Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fiona Dodd
Northumbria University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2026
First Posted
June 15, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- Fully accessible
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.