Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-29
Brief Title:
Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The loss of skeletal muscle mass and function usually occurs with aging known as primary sarcopenia Sarcopenia has a prevalence of 116 among the elderly population in China and is closely associated with increased risks of falls disability and mortality Currently there is a lack of definition criteria for sarcopenia based on biomarkers The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration Therefore this study aims to explore the effects of symbiotic and whey protein on muscle gut microbiota and clinical outcomes among sarcopenia patients to provide a reference for further diagnosis and treatment of sarcopenia
Detailed Description:
This study will last 12 weeks For the duration of the study an anticipated total of 120 participants will be randomly assigned to three groups During the study visits questionnaires blood and stool collection and functional testing will occur Intention-to-treat analysis ITT and per-protocol analysis PP will be conducted in statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None