Cognitive Task Sensitivity in Perimenopause and Nutritional Status
2026년 6월 12일 업데이트: Northumbria University
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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
관찰
등록 (추정된)
60
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Fiona Dodd
- 전화번호: +44 1912273377
- 이메일: f.dodd@northumbria.ac.uk
연구 장소
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Tyne & Wear
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Newcastle upon Tyne, Tyne & Wear, 영국, NE1 8ST
- School of Psychology, Northumbria University
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연락하다:
- Fiona Dodd
- 전화번호: 3377 0191 2273377
- 이메일: f.dodd@northumbria.ac.uk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numeric working memory task % accuracy
기간: Baseline
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Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
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Baseline
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Numeric working memory task reaction time
기간: Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
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3-back task % accuracy
기간: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
3-back task reaction time
기간: Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
3-back task number of false alarms
기간: Baseline
|
Cognitive function - working memory task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
|
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Corsi blocks task score
기간: Baseline
|
Cognitive function - working memory task.
Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance
|
Baseline
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Alphabetic working memory task % accuracy
기간: Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Alphabetic working memory task reaction time
기간: Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
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|
Word recognition % accuracy
기간: Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
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Baseline
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Word recognition reaction time
기간: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Picture recognition % accuracy
기간: Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
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Picture recognition reaction time
기간: Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
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Stroop task % accuracy
기간: Baseline
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Cognitive function - selective attention and inhibitory control task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
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Stroop task reaction time
기간: Baseline
|
Cognitive function - selective attention and inhibitory control task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
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Digit vigilance task % accuracy
기간: Baseline
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Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
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Digit vigilance task reaction time
기간: Baseline
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Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
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Digit vigilance number of false alarms
기간: Baseline
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Cognitive function - attention task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
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Choice reaction time task % accuracy
기간: Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
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Choice reaction time task reaction time
기간: Baseline
|
Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Menopause symptom severity
기간: Past 6 months
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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.
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Past 6 months
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Brain fog severity
기간: Past 6 months
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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.
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Past 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Fiona Dodd, Northumbria University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2026년 7월 1일
연구 완료 (추정된)
2026년 7월 1일
연구 등록 날짜
최초 제출
2026년 6월 8일
QC 기준을 충족하는 최초 제출
2026년 6월 12일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 12일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 12197
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
IPD 공유 기간
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.
IPD 공유 액세스 기준
Fully accessible
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .