Cognitive Task Sensitivity in Perimenopause and Nutritional Status
2026年6月12日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
观察性的
注册 (估计的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fiona Dodd
- 电话号码：+44 1912273377
- 邮箱：f.dodd@northumbria.ac.uk
学习地点
-
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Tyne & Wear
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Newcastle upon Tyne、Tyne & Wear、英国、NE1 8ST
- School of Psychology, Northumbria University
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接触：
- Fiona Dodd
- 电话号码：3377 0191 2273377
- 邮箱：f.dodd@northumbria.ac.uk
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numeric working memory task % accuracy
大体时间：Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Numeric working memory task reaction time
大体时间：Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
3-back task % accuracy
大体时间：Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
3-back task reaction time
大体时间：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
大体时间：Baseline
|
Cognitive function - working memory task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
|
|
Corsi blocks task score
大体时间：Baseline
|
Cognitive function - working memory task.
Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance
|
Baseline
|
|
Alphabetic working memory task % accuracy
大体时间：Baseline
|
Cognitive function - working memory task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Alphabetic working memory task reaction time
大体时间：Baseline
|
Cognitive function - working memory task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Word recognition % accuracy
大体时间：Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Word recognition reaction time
大体时间：Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Picture recognition % accuracy
大体时间：Baseline
|
Cognitive function - episodic memory.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Picture recognition reaction time
大体时间：Baseline
|
Cognitive function - episodic memory.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Stroop task % accuracy
大体时间：Baseline
|
Cognitive function - selective attention and inhibitory control task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Stroop task reaction time
大体时间：Baseline
|
Cognitive function - selective attention and inhibitory control task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Digit vigilance task % accuracy
大体时间：Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Digit vigilance task reaction time
大体时间：Baseline
|
Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
|
Digit vigilance number of false alarms
大体时间：Baseline
|
Cognitive function - attention task.
Measured as number of errors with a lower score indicating better performance.
|
Baseline
|
|
Choice reaction time task % accuracy
大体时间：Baseline
|
Cognitive function - attention task.
Measured as a percentage, with a higher score indicating better performance
|
Baseline
|
|
Choice reaction time task reaction time
大体时间：Baseline
|
Cognitive function - attention task.
Measured as correct reaction time (in milliseconds) with a lower score indicating better performance.
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Menopause symptom severity
大体时间：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.
|
Past 6 months
|
|
Brain fog severity
大体时间：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.
|
Past 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Fiona Dodd、Northumbria University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2026年7月1日
研究注册日期
首次提交
2026年6月8日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月15日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 12197
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享时间框架
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 共享访问标准
Fully accessible
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.