Cognitive Task Sensitivity in Perimenopause and Nutritional Status

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perimenopause; Cognitive Function in Perimenopause

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Fiona Dodd; Phone Number: +44 1912273377; Email: f.dodd@northumbria.ac.uk

Study Locations

• United Kingdom
  • Tyne & Wear
    • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
      • School of Psychology, Northumbria University
      • Contact: Fiona Dodd; Phone Number: 3377 0191 2273377; Email: f.dodd@northumbria.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause symptom severity	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	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

Collaborators and Investigators

• Sponsor: Northumbria University
• Investigators: Principal Investigator: Fiona Dodd, Northumbria University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Nutrition; Diet; Cognitive Function; Perimenopause; Brain Fog; Menopause Rating Scale; Food Frequency Questionaire
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Mental Fatigue
• Other Study ID Numbers: 12197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 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.
• IPD Sharing Access Criteria: Fully accessible
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No