PerimenopauseNCT07648667
Cognitive Task Sensitivity in Perimenopause and Nutritional Status
An observational study of Perimenopause and Cognitive Function in Perimenopause, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Cognitive Function in Perimenopause
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
School of Psychology, Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
Fiona Dodd, 0191 2273377 ext. 3377, f.dodd@northumbria.ac.uk
About this study
Official title: 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.
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.
- Conditions
- Perimenopause, Cognitive Function in Perimenopause
- Keywords
- Perimenopause, Cognitive Function, Brain Fog, Diet, Nutrition, Food Frequency Questionaire, Menopause Rating Scale
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Numeric working memory task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Measured: 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.
Measured: Baseline
3-back task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Alphabetic working memory task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
Measured: 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.
Measured: Baseline
Word recognition % accuracy
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Measured: Baseline
Word recognition reaction time
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Measured: Baseline
Picture recognition % accuracy
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
Measured: Baseline
Picture recognition reaction time
Cognitive function - episodic memory. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Measured: Baseline
Stroop task % accuracy
Cognitive function - selective attention and inhibitory control task. Measured as a percentage, with a higher score indicating better performance
Measured: 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.
Measured: Baseline
Digit vigilance task % accuracy
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Measured: Baseline
Digit vigilance task reaction time
Cognitive function - attention task. Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
Measured: Baseline
Digit vigilance number of false alarms
Cognitive function - attention task. Measured as number of errors with a lower score indicating better performance.
Measured: Baseline
Choice reaction time task % accuracy
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: Past 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiona Dodd, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648667
- Sponsor's protocol ID
- 12197
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing Cognitive Task Sensitivity in Perimenopause and Its Association With Nutritional Status
- ClinicalTrials.gov ID
- NCT07648667
- Acronym / sponsor ID
- 12197
- Conditions
- Perimenopause, Cognitive Function in Perimenopause
- Keywords
- Perimenopause, Cognitive Function, Brain Fog, Diet, Nutrition, Food Frequency Questionaire, Menopause Rating Scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric working memory task % accuracy
Time frame: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
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-back task % accuracy
Time frame: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
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.
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.
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
Alphabetic working memory task % accuracy
Time frame: Baseline
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance
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.
Word recognition % accuracy
Time frame: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
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.
Picture recognition % accuracy
Time frame: Baseline
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance
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.
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
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.
Digit vigilance task % accuracy
Time frame: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
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.
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.
Choice reaction time task % accuracy
Time frame: Baseline
Cognitive function - attention task. Measured as a percentage, with a higher score indicating better performance
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.
2 secondary outcomes
Menopause symptom severity
Time frame: Past 6 months
Brain fog severity
Time frame: Past 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiona Dodd principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimenopause and Cognitive Function in Perimenopause, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiona Dodd (+44 1912273377, f.dodd@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric working memory task % accuracy (time frame: Baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.