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Body Composition ChangesHER-KZNCT07675486

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

An observational study of Body Composition Changes and Dietary Intakes, run by Nazarbayev University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Body Composition Changes, Dietary Intakes, Sleep
How many people
200 participants
Where
No sites listed yet
Study dates
Jul 2026to Jul 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • Adult, Older adult

Study population: Participants will be identified from the pool of women attending clinically-ordered DEXA examinations.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mei Yen Chan contact

+7 7172 69 4968

yen.chan@nu.edu.kz

Tairkhan Dautov contact

tairkhan.dautov@gmail.com

About this study

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

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.

Medical subject headings
Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat Mass Index (FMI)

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

    Measured: Assessed at a single study visit during enrollment

  2. Bone mineral density (BMD)

    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.

    Measured: Assessed at a single study visit during enrollment

  3. Fat-Free Mass Index (FFMI)

    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.

    Measured: Assessed at a single study visit during enrollment

  4. Visceral Adipose Tissue (VAT)

    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.

    Measured: Assessed at a single study visit during enrollment

  5. Appendicular lean mass index (ALMI)

    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.

    Measured: Assessed at a single study visit during enrollment

  6. Appendicular skeletal muscle mass and index (ASMI)

    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.

    Measured: Assessed at a single study visit during enrollment

  7. Body Mass Index (BMI)

    Measured: Assessed at a single study visit during enrollment

Secondary outcomes (4)

  1. SARC-F Score

    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.

    Measured: Assessed at a single study visit during enrollment

  2. Rapid Eating Assessment for Participants - dietary quality score

    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.

    Measured: Assessed at a single study visit during enrollment

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

    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.

    Measured: Assessed at a single study visit during enrollment

  4. Pittsburgh Sleep Quality Index (PSQI) Global Score

    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.

    Measured: Assessed at a single study visit during enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07675486
Sponsor's protocol ID
201223FD2603
Acronym
HER-KZ
Status last verified
Jun 2026
First submitted
18 Jun 2026
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Body Composition Changes and Dietary Intakes, run by Nazarbayev University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mei Yen Chan (+7 7172 69 4968, yen.chan@nu.edu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat Mass Index (FMI) (time frame: Assessed at a single study visit during enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07675486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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