From Exposome to Health Outcomes: A Population-Based Approach to Understanding and Mitigating Early Menopause in Singapore's Diverse Communities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Early menopause
研究概览
简要总结
Brief Summary
The goal of this observational study is to learn how environmental factors, lifestyle choices, and social conditions affect the timing of menopause in Asian women aged 40-50 years living in Singapore. The main aims of the project are the following:
- Do environmental pollutants and lifestyle exposures contribute to earlier menopause in Asian women?
- What biological changes occur when women are exposed to harmful environmental factors during menopause transition?
Participants will be followed for 18 months and will complete questionnaires about their health history, lifestyle, diet, and environmental exposures. Participants will provide blood, urine, stool, hair, and nail samples for laboratory analysis and undergo basic health assessments including weight, blood pressure, and bone density measurements. Participants will wear activity monitors and air pollution sensors for 7 days and attend follow-up visits at 6 months, 12 months, and 18 months to track changes in their health. This data will be obtained during the baseline visit.
详细描述
Detailed Description
Background and Rationale: Early menopause, defined as cessation of ovarian function before age 45, affects approximately 5-12% of women globally and is associated with increased risks of cardiovascular disease, osteoporosis, and cognitive decline. Growing evidence suggests that environmental exposures, including persistent organic pollutants, air pollution, and endocrine-disrupting chemicals, may accelerate ovarian aging and contribute to earlier menopausal timing. The exposome concept involves the totality of environmental exposures experienced by individuals throughout their lifetimes, including chemical, physical, biological, and social factors.
Study Hypothesis We hypothesize that combined exposure to environmental pollutants, lifestyle factors, and social conditions accelerates biological aging processes and leads to earlier menopause onset in women. These exposome effects are mediated through changes in gene expression patterns, metabolic profiles, and gut microbiome composition, ultimately increasing the risk of adverse health outcomes.
Study Design: This is a prospective observational cohort study employing a longitudinal design with 18-month follow-up. The study integrates comprehensive exposome assessment with multi-omics profiling to investigate the complex relationships between environmental factors and menopausal health outcomes in a multi-ethnic Asian population.
Population and Setting: Four hundred women aged 40-50 years will be recruited from diverse communities across Singapore. Participants must have experienced no menstruation for the last 2 months or irregular menstrual cycles in the last 6 months, be proficient in English, and plan to reside in Singapore for the study duration. The study will include Chinese, Malay, and Indian ethnicities reflecting Singapore's demographic composition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 40-50 years No menstruation for the last 2 months or irregular menstrual cycles in the last 6 months Chinese, Malay, or Indian ethnicity Proficient in English language Planning to reside in Singapore for next 2 years Willing to provide informed consent and comply with study procedures
排除标准
- •In menopause (12 consecutive months without menstruation) Currently pregnant or planning to conceive History of bilateral oophorectomy and/or hysterectomy Currently receiving hormone therapy, including estradiol replacement therapy or oral contraceptives Diagnosed with premature ovarian insufficiency before 40 years of age Diagnosis of autoimmune conditions and/or chromosomal abnormalities known to affect ovarian function Diagnosis of severe cognitive impairment and/or mental disorders Received cancer treatment in the past 12 months
结局指标
主要结局
Early menopause
时间窗: 18 months
Time to menopause onset
时间窗: 18 months
• Menopausal symptom severity score using standardized assessment tools
次要结局
未报告次要终点
研究者
Kothandaraman Narasimhan, Ph.D.
Principal Investigator
Institute for Human Development and Potential (IHDP), Singapore
