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临床试验/CTRI/2024/10/076052
CTRI/2024/10/076052尚未招募不适用

Role of Micronutrient Levels on Cognitive Function and Quality of Life in Perimenopausal Women

Manipal College of Health Professions1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2024年11月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
127
试验地点
1
主要终点
Cognitive function score: MoCA score

研究概览

简要总结

Micronutrient sufficiency is essential for maintaining normal cognitive function. Insufficient levels of vitamin D and B and minerals such as iron, magnesium, and zinc have been associated with cognitive decline in menopausal women. However, these factors have not been studied extensively during the perimenopausal period, which may be critical for promoting optimal health during menopause. Understanding the significance of these factors is crucial for developing public health guidelines aimed at raising awareness and preventing health issues such as Alzheimer’s disease, dementia, and stroke. Methods for estimation of micronutrients will be optimized using standard and pilot run of 5-10 blood samples. Participants who come for routine checkups and have routine blood investigations will be recruited after obtaining informed consent from the OBG department, KMC Manipal. Sociodemographic data, including dietary patterns and habits, stress, and physical activity, will be collected from the participants. Quality of life will be assessed using the MENQOL questionnaire. Cognitive assessment will be performed using the Montreal Cognitive Assessment tool (MoCA) with the help of a Speech-language pathologist. Kannada-making and verbal learning tests will be used to assess cognitive function. Additional 4ml of blood samples will be collected during their routine blood investigation, or leftover samples will be obtained from the lab in charge after completing requested lab investigations by producing a patient consent form. Serum samples will be separated from blood and stored at -20°C to analyze nutritional biomarkers. Oxidative and mitochondrial stress markers will be assessed.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Having an irregular menstrual cycle as per STRAW criteria.

排除标准

  • Postmenopausal women.
  • Women who have undergone hysterectomy and/or oophorectomy, are on hormonal replacement therapy, are using any contraceptive aids, or are diagnosed with any condition causing unnatural cessation of menses.
  • Women with a history of cognitive impairment or any other brain dysfunctions.
  • Individuals with bleeding or clotting disorders.
  • Those who are taking supplementation of micronutrients.
  • Those who have a chronic illness (cancer, psychological, etc.).
  • Women reporting hearing loss.

结局指标

主要结局

Cognitive function score: MoCA score

时间窗: At the time of routine blood investigation

Kannada trial test score

时间窗: At the time of routine blood investigation

Verbal learning test score

时间窗: At the time of routine blood investigation

Complete blood picture

时间窗: At the time of routine blood investigation

Mineral profile: Iron, magnesium and zinc

时间窗: At the time of routine blood investigation

Vitamin profile: vitamin B and D

时间窗: At the time of routine blood investigation

Menopause-specific Quality of Life (MENQOL) score

时间窗: At the time of routine blood investigation

Perceived stress scale (PSS)

时间窗: At the time of routine blood investigation

Food frequency questionnaire and 24-hour recall test

时间窗: At the time of routine blood investigation

Global physical activity questionnaire

时间窗: At the time of routine blood investigation

次要结局

  • Oxidative stress markers(Mitochondrial stress markers)

研究者

发起方
Manipal College of Health Professions
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

KISHAN S KULAL

Manipal College of Health Professions

研究点 (1)

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