- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07675486
Health, Body Composition, and Nutrition Research Among Women in Kazakhstan (HER-KZ)
June 26, 2026 updated by: Mei Yen Chan, Nazarbayev University
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.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mei Yen Chan
- Phone Number: +7 7172 69 4968
- Email: yen.chan@nu.edu.kz
Study Contact Backup
- Name: Tairkhan Dautov
- Email: tairkhan.dautov@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Participants will be identified from the pool of women attending clinically-ordered DEXA examinations.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
|
Body Mass Index (BMI)
Time Frame: Assessed at a single study visit during enrollment
|
Assessed at a single study visit during enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
|
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.
|
Assessed at a single study visit during enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Study Registration Dates
First Submitted
June 18, 2026
First Submitted That Met QC Criteria
June 26, 2026
First Posted (Actual)
June 30, 2026
Study Record Updates
Last Update Posted (Actual)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 26, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201223FD2603
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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