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临床试验/NCT07675486
NCT07675486尚未招募不适用

Understanding Women's Health in Kazakhstan: Body Composition as a Key Indicator for Precision Nutrition and Predictive Healthcare

Nazarbayev University0 个研究点目标入组 200 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Fat Mass Index (FMI)

研究概览

简要总结

This study aims to investigate the association between dietary intake, physical activity, sleep quality, and body composition in women in Kazakhstan. The study will recruit approximately 200 women aged 20 years and older undergoing routine DEXA examinations in Astana. Participants will complete validated questionnaires assessing diet, physical activity, sleep quality, and sarcopenia risk, alongside functional assessments. DEXA scans will provide measurements of fat mass, lean mass, visceral adipose tissue, bone mineral density, and appendicular skeletal muscle mass. The primary objective is to evaluate associations between dietary quality and DEXA-derived outcomes. Secondary objectives include assessing sarcopenia prevalence and examining relationships between physical activity, sleep quality, supplement use, and body composition. An optional second stage will explore associations between body composition and existing inflammatory and metabolic biomarkers from medical records. The findings are expected to provide the first comprehensive DEXA-based dataset on women's body composition and lifestyle factors in Kazakhstan and inform public health strategies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female sex
  • Age ≥20 years at the time of consent
  • Natural postmenopause (≥12 consecutive months of amenorrhoea not attributable to other pathological or pharmacological causes) OR surgical postmenopause (bilateral oophorectomy)
  • Resident of Astana or the surrounding region with no planned relocation during the study period
  • Able to provide written informed consent independently
  • Able to complete the questionnaire in Kazakh, Russian, or English

排除标准

  • Active malignancy or systemic anti-cancer treatment (chemotherapy, radiotherapy, immunotherapy) within the past 5 years
  • Conditions causing secondary changes in muscle mass or body composition: hyperthyroidism (untreated), Cushing's syndrome, acromegaly, severe liver disease (Child-Pugh B or C), advanced chronic kidney disease (Stage 4 or 5, eGFR <30 ml/min/1.73 m²)
  • Neuromuscular disorders that independently affect skeletal muscle mass (e.g., myopathy, motor neurone disease, multiple sclerosis)
  • Long-term systemic corticosteroid therapy (>3 months in the past year, equivalent to ≥5 mg/day prednisolone)
  • Severe skeletal deformity (kyphoscoliosis, limb absence) or presence of metallic implants (hip or knee prosthesis on both sides, bilateral rods) that would significantly compromise DEXA body composition validity
  • Physical inability to stand or to complete the functional assessments safely
  • Cognitive impairment or psychiatric condition precluding independent informed consent, as determined by the recruiting research team member

结局指标

主要结局

Fat Mass Index (FMI)

时间窗: Assessed at a single study visit during enrollment

FMI in kg/m², measured by dual-energy X-ray absorptiometry (DEXA). Higher values indicate greater adiposity and a less favorable body composition profile.

Bone mineral density (BMD)

时间窗: Assessed at a single study visit during enrollment

BMD in g/cm², measured using dual-energy X-ray absorptiometry (DEXA). Higher values indicate greater bone mineral density and generally better bone health, whereas lower values indicate reduced bone mineral density.

Fat-Free Mass Index (FFMI)

时间窗: Assessed at a single study visit during enrollment

FFMI in kg/m², calculated as total fat-free mass (kg) divided by height squared (m²), and measured using dual-energy X-ray absorptiometry (DEXA). Higher values indicate greater fat-free mass relative to height and a more favorable body composition profile.

Visceral Adipose Tissue (VAT)

时间窗: Assessed at a single study visit during enrollment

Measured using dual-energy X-ray absorptiometry (DEXA) and reported as visceral fat mass in grams (g) or kilograms (kg). Higher values indicate greater accumulation of visceral adipose tissue and a less favorable body composition profile.

Appendicular lean mass index (ALMI)

时间窗: Assessed at a single study visit during enrollment

ALMI in kg/m², calculated as the sum of lean mass from both arms and legs (kg) divided by height squared (m²), and measured by dual-energy X-ray absorptiometry (DEXA). This is a continuous measure and does not have a predefined minimum or maximum value. Higher values indicate greater appendicular lean mass.

Appendicular skeletal muscle mass and index (ASMI)

时间窗: Assessed at a single study visit during enrollment

ASMI in kg/m², calculated as the appendicular skeletal muscle mass (sum of lean soft tissue mass of the arms and legs, kg) divided by height squared (m²), and measured using dual-energy X-ray absorptiometry (DEXA). This is a continuous measure and has no predefined minimum or maximum value. Higher values indicate greater appendicular skeletal muscle mass.

Body Mass Index (BMI)

时间窗: Assessed at a single study visit during enrollment

次要结局

  • SARC-F Score(Assessed at a single study visit during enrollment)
  • Rapid Eating Assessment for Participants - dietary quality score(Assessed at a single study visit during enrollment)
  • IPAQ-SF Physical Activity (International Physical Activity Questionnaire - Short Form)(Assessed at a single study visit during enrollment)
  • Pittsburgh Sleep Quality Index (PSQI) Global Score(Assessed at a single study visit during enrollment)

研究者

发起方
Nazarbayev University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei Yen Chan

Principal Investigator, Central Asia Food Innovation Lab, School of Medicine

Nazarbayev University

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