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Health, Body Composition, and Nutrition Research Among Women in Kazakhstan (HER-KZ)

26. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Typ studie

Pozorovací

Zápis (Odhadovaný)

200

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

N/A

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fat Mass Index (FMI)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Assessed at a single study visit during enrollment
Assessed at a single study visit during enrollment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
SARC-F Score
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. července 2029

Dokončení studie (Odhadovaný)

1. července 2029

Termíny zápisu do studia

První předloženo

18. června 2026

První předloženo, které splnilo kritéria kontroly kvality

26. června 2026

První zveřejněno (Aktuální)

30. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 201223FD2603

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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