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NCT Number: NCT07675486

Health, Body Composition, and Nutrition Research Among Women in Kazakhstan

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Fat Mass Index (FMI)

    Time frame: 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.

  2. Bone mineral density (BMD)

    Time frame: 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.

  3. Fat-Free Mass Index (FFMI)

    Time frame: 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.

  4. Visceral Adipose Tissue (VAT)

    Time frame: 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.

  5. Appendicular lean mass index (ALMI)

    Time frame: 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.

  6. Appendicular skeletal muscle mass and index (ASMI)

    Time frame: 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.

  7. Body Mass Index (BMI)

    Time frame: Assessed at a single study visit during enrollment

Secondary outcomes

  1. SARC-F Score

    Time frame: Assessed at a single study visit during enrollment

    A self-reported screening tool consisting of five items evaluating strength, assistance with walking, rising from a chair, climbing stairs, and falls. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater risk of sarcopenia and poorer physical function, with scores ≥4 suggesting probable sarcopenia.

  2. Rapid Eating Assessment for Participants - dietary quality score

    Time frame: Assessed at a single study visit during enrollment

    A 19-item questionnaire evaluating food sufficiency, healthy eating patterns, foods to limit, salt intake, alcohol consumption, and dietary supplement use. Each item is rated on a 4-point frequency scale. Responses are summed to generate a total dietary quality score ranging from 19 to 76, with higher scores indicating better overall dietary quality and greater adherence to healthy dietary practices.

  3. IPAQ-SF Physical Activity (International Physical Activity Questionnaire - Short Form)

    Time frame: Assessed at a single study visit during enrollment

    Evaluates the frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity over the past 7 days. Responses are converted into metabolic equivalent task (MET)-minutes per week. Total physical activity score has no fixed minimum or maximum value, as it is a continuous measure. Higher scores indicate greater levels of physical activity.

  4. Pittsburgh Sleep Quality Index (PSQI) Global Score

    Time frame: Assessed at a single study visit during enrollment

    A 19-item questionnaire that evaluates sleep quality and disturbances over the past month across seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each component is scored from 0 to 3, yielding a total global score ranging from 0 to 21. Higher scores indicate poorer sleep quality, with scores >5 generally indicating poor sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Yen Chan

CONTACT

[email protected]

+7 7172 69 4968

Tairkhan Dautov

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nazarbayev University

Other

Registry information

Official study title

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

Acronym: HER-KZ

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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