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Набор скоро начнётся NCT07648667

Cognitive Task Sensitivity in Perimenopause and Nutritional Status

— Наблюдательное Perimenopause Cognitive Function in Perimenopause

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Perimenopause, Cognitive Function in Perimenopause. Базовые параметры: 40 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

Pilot Study Assessing Cognitive Task Sensitivity in Perimenopause and Its Association With Nutritional Status

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Numeric working memory task % accuracy [Срок оценки: Baseline]
  • Numeric working memory task reaction time [Срок оценки: Baseline]
  • 3-back task % accuracy [Срок оценки: Baseline]
  • 3-back task reaction time [Срок оценки: Baseline]
  • 3-back task number of false alarms [Срок оценки: Baseline]
  • Corsi blocks task score [Срок оценки: Baseline]
  • Alphabetic working memory task % accuracy [Срок оценки: Baseline]
  • Alphabetic working memory task reaction time [Срок оценки: Baseline]
  • Word recognition % accuracy [Срок оценки: Baseline]
  • Word recognition reaction time [Срок оценки: Baseline]
Вторичные конечные точки (2)
  • Menopause symptom severity [Срок оценки: Past 6 months]
  • Brain fog severity [Срок оценки: Past 6 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Великобритания · 1 центр
  • School of Psychology, Northumbria University — Newcastle upon Tyne

Идентификаторы

NCT: NCT07648667 · 12197

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗