Cognitive Task Sensitivity in Perimenopause and Nutritional Status
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-55
SponsorNorthumbria University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Perimenopausal women who report being severely affected by cognition-related/brain fog symptoms
Group B: Perimenopausal women who do not report being severely affected by cog-related/brain fog symptoms
Trial outcomes
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
Baseline2
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
Baseline3
3-back task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Time frame
Baseline4
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
BaselineSecondary 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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
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