- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Taoyuan, Taiwan
- Chang Gung University of Science and Technology
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Case group
Possible sarcopenia
|
NON
|
|
Control group
Non-possible sarcopenia
|
NON
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Based on the results of empirical research on sarcopenia in Asian countries, a diagnostic consensus was established.
Tidsramme: baseline
|
|
baseline
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202402045B0
- NMRPF3Q0291 (Anden identifikator: Chang Gung University of Science and Technology)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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