School of Psychology, Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom
NCT Number: NCT07648667
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 opening soon.
Get Notified40 year–55 year
Female
Observational
Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Time frame: Baseline
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Time frame: Baseline
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - working memory task. Measured as number of errors with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance
Time frame: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Time frame: Baseline
Cognitive function - working memory task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Time frame: Baseline
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Time frame: Baseline
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - selective attention and inhibitory control task. Measured as a percentage, with a higher score indicating better performance
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.
Time frame: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Time frame: Baseline
Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - attention task. Measured as number of errors with a lower score indicating better performance.
Time frame: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Time frame: Baseline
Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
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.
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.
Contact information is provided by the study sponsor or research team.
Northumbria University
Other
Pilot Study Assessing Cognitive Task Sensitivity in Perimenopause and Its Association With Nutritional Status
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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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