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NCT Number: NCT07648667

Cognitive Task Sensitivity in Perimenopause and 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.

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Key information

Age range

40 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

School of Psychology, Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location contact

Fiona Dodd

CONTACT

[email protected]

0191 2273377 ext. 3377

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Numeric working memory task % accuracy

    Time frame: Baseline

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

  2. Numeric working memory task reaction time

    Time frame: Baseline

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

  3. 3-back task % accuracy

    Time frame: Baseline

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

  4. 3-back task reaction time

    Time frame: Baseline

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

  5. 3-back task number of false alarms

    Time frame: Baseline

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

  6. Corsi blocks task score

    Time frame: Baseline

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

  7. Alphabetic working memory task % accuracy

    Time frame: Baseline

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

  8. Alphabetic working memory task reaction time

    Time frame: Baseline

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

  9. Word recognition % accuracy

    Time frame: Baseline

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

  10. Word recognition reaction time

    Time frame: Baseline

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

  11. Picture recognition % accuracy

    Time frame: Baseline

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

  12. Picture recognition reaction time

    Time frame: Baseline

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

  13. Stroop task % accuracy

    Time frame: Baseline

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

  14. Stroop task reaction time

    Time frame: Baseline

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

  15. Digit vigilance task % accuracy

    Time frame: Baseline

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

  16. Digit vigilance task reaction time

    Time frame: Baseline

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

  17. Digit vigilance number of false alarms

    Time frame: Baseline

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

  18. Choice reaction time task % accuracy

    Time frame: Baseline

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

  19. Choice reaction time task reaction time

    Time frame: Baseline

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

Secondary outcomes

  1. Menopause symptom severity

    Time frame: 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.

  2. Brain fog severity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fiona Dodd

CONTACT

[email protected]

+44 1912273377

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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