- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07658612
Research on the Possible Relationship Between Sarcopenia and Oral Muscle Function (GSOM)
A Study on the Correlation Between the Genetic Polymorphisms of Elderly Individuals in the Community and Possible Sarcopenia and Oral Muscle Function
This study will focus on community-dwelling elderly individuals and will follow the community screening process recommended by AWGS.
It is expected to recruit 100 individuals who may have sarcopenia and 300 healthy or sub-healthy elderly individuals who are not likely to have sarcopenia, totaling 400 participants.Basic data such as age and body composition will be collected, as well as dietary records (three days), nutritional status assessments (Mini Nutritional Assessment, MNA), and oral health status records (including records of missing teeth, the number of opposing teeth, and whether participants wear fixed or removable dentures).
Chewing and swallowing abilities will be recorded using the Eating Assessment Tool (EAT-10). In a non-invasive manner, saliva samples will be collected for genomic DNA (gDNA) extraction, followed by quantitative gDNA typing analysis of seven gene loci (shown in Table 3).
Genotype data will be statistically analyzed along with participants' basic information, relevant sarcopenia screening data, and parameters related to oral health and swallowing function. This study adopts a case-control experimental design with the following objectives:
- to explore the incidence of possible sarcopenia in community-dwelling elderly.
- to investigate the relationship between oral function and possible sarcopenia in community-dwelling elderly using tongue pressure measurements.
- to understand the correlation between sarcopenia risk in community-dwelling elderly and seven specific genes.
- to examine the relationship between oral function and seven specific genes in community-dwelling elderly.
- to investigate the relationship between tongue pressure measurements and the values measured using edible chewing gum.
- to establish a standard test for evaluating oral chewing function using edible chewing gum.
By examining the possible mechanisms of the different genes involved in the causes of sarcopenia, we aim to find prevention strategies that are suitable for participants with different gene types.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Taoyuan, Taïwan
- Chang Gung University of Science and Technology
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Case group - Inclusion Criteria:
- aged 60 years (inclusive) or older
- general public or residing in an institution for 3 months (inclusive) or more
- willing to participate in the experimental design and sign the consent form
- able to eat independently by mouth
- identified by researchers as possibly having sarcopenia
Control group-Inclusion Criteria:
- aged 60 years (inclusive) or older
- general public or residing in an institution for 3 months (inclusive) or more ●willing to participate in the experimental design and sign the consent form
- able to eat independently by mouth
- identified by researchers as not possibly having sarcopenia
Case group 、Control group- Exclusion Criteria:
- having comorbidities, critical illnesses, undergoing major surgeries, cancer, renal failure, liver failure, kidney diseases, liver diseases, having malignant tumors in the past five years, inflammation symptoms (C-reactive protein >10mg/dl)
- severely malnourished individuals (GNRI < 82)
- long-term tube-fed individuals.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Case group
Possible sarcopenia
|
NON
|
|
Control group
Non-possible sarcopenia
|
NON
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Based on the results of empirical research on sarcopenia in Asian countries, a diagnostic consensus was established.
Délai: baseline
|
|
baseline
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202402045B0
- NMRPF3Q0291 (Autre identifiant: Chang Gung University of Science and Technology)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .