NCT06347835

Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% 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.

Conditions

• Sarcopenia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	symbiotic	The intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification.
DIETARY_SUPPLEMENT	whey protein	The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification.
DIETARY_SUPPLEMENT	symbiotic placebo	The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.
DIETARY_SUPPLEMENT	whey protein placebo	The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-04-01
• Completion: 2026-01-01
• First posted: 2024-04-04
• Last updated: 2024-04-22

Locations

1 site across 1 country: China