ClinicalTrials.gg
Not yet recruitingNCT07648667Updated Jun 15, 2026

Cognitive Task Sensitivity in Perimenopause and Nutritional Status

An observational study in Perimenopause and Cognitive Function in Perimenopause, sponsored by Northumbria University. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Northumbria University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
40 Years to 55 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Perimenopause
  • Cognitive Function in Perimenopause

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Keywords

  • Perimenopause
  • Cognitive Function
  • Brain Fog
  • Diet
  • Nutrition
  • Food Frequency Questionaire
  • Menopause Rating Scale
03

In context

Mental Fatigue

175 studies on the registry are indexed under Mental Fatigue; 54 are open to participants now.

This study's planned enrollment of 60 is below the median of 73 across 32 observational studies indexed under Mental Fatigue.

Browse Mental Fatigue studies →

Lead sponsor

Northumbria University is the lead sponsor of 160 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (defined as 12 months with no periods)
  • Non-smoker (including vaping)
  • Not lactating or pregnant (or seeking pregnancy)
  • Oral and hormone replacement therapy allowed if taken for at least 3 months prior
  • Cognitive symptoms/brain fog are not required for participation

Exclusion criteria

Exclusion Criteria:

  • (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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Numeric working memory task % accuracy

    Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 3-back task % accuracy

    Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  4. 3-back task reaction time

    Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.

    Time frame: Baseline

  5. 3-back task number of false alarms

    Cognitive function - working memory task. Measured as number of errors with a lower score indicating better performance.

    Time frame: Baseline

  6. Corsi blocks task score

    Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance

    Time frame: Baseline

  7. Alphabetic working memory task % accuracy

    Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  8. 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.

    Time frame: Baseline

  9. Word recognition % accuracy

    Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  10. Word recognition reaction time

    Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.

    Time frame: Baseline

  11. Picture recognition % accuracy

    Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  12. Picture recognition reaction time

    Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.

    Time frame: Baseline

  13. Stroop task % accuracy

    Cognitive function - selective attention and inhibitory control task. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  14. 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.

    Time frame: Baseline

  15. Digit vigilance task % accuracy

    Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  16. Digit vigilance task reaction time

    Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.

    Time frame: Baseline

  17. Digit vigilance number of false alarms

    Cognitive function - attention task. Measured as number of errors with a lower score indicating better performance.

    Time frame: Baseline

  18. Choice reaction time task % accuracy

    Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance

    Time frame: Baseline

  19. Choice reaction time task reaction time

    Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Past 6 months

  2. 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.

    Time frame: Past 6 months

07

Study locations

1 site
  • School of Psychology, Northumbria University
    Newcastle upon Tyne, Tyne & Wear NE1 8ST, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Jul 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2026
First posted
Jun 15, 2026
StartEst.
Jun 2026
Primary completionEst.
Jul 2026
CompletionEst.
Jul 2026
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07648667
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Fiona Dodd
Contact
f.dodd@northumbria.ac.uk
+44 1912273377
Fiona Dodd
principal investigator · Northumbria University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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