- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07675486
Health, Body Composition, and Nutrition Research Among Women in Kazakhstan (HER-KZ)
26 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Type d'étude
Observationnel
Inscription (Estimé)
200
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mei Yen Chan
- Numéro de téléphone: +7 7172 69 4968
- E-mail: yen.chan@nu.edu.kz
Sauvegarde des contacts de l'étude
- Nom: Tairkhan Dautov
- E-mail: tairkhan.dautov@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
N/A
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Participants will be identified from the pool of women attending clinically-ordered DEXA examinations.
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fat Mass Index (FMI)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Assessed at a single study visit during enrollment
|
Assessed at a single study visit during enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SARC-F Score
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 juillet 2029
Achèvement de l'étude (Estimé)
1 juillet 2029
Dates d'inscription aux études
Première soumission
18 juin 2026
Première soumission répondant aux critères de contrôle qualité
26 juin 2026
Première publication (Réel)
30 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201223FD2603
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
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