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

Not Applicable

Not yet recruiting

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: symbiotic; Dietary Supplement: symbiotic placebo; Dietary Supplement: whey protein; Dietary Supplement: whey protein placebo

• Registration Number: NCT06347835
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Posted: 2024-04-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Primary Completion: 2025-04
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age 65 and older
2. Can cooperate with the measurement and questionnaire survey
3. Meets Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria for sarcopenia
4. Obtain informed consent to participate in this study

Exclusion Criteria

1. Severe complications
2. Suffers from neuromuscular related diseases
3. Immobility
4. Have taken antibiotics, probiotics and other medications that may affect the gut microbiota in the last 6 weeks
5. Implants of electronic devices or metal objects in the body

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
symbiotic and whey protein intervention	whey protein	This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks
symbiotic and whey protein intervention	symbiotic	This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks
whey protein intervention	whey protein	This group received dietary guidance and whey protein intervention for 12 weeks
control	symbiotic placebo	This group received dietary guidance and maltodextrin for 12 weeks
whey protein intervention	symbiotic placebo	This group received dietary guidance and whey protein intervention for 12 weeks
control	whey protein placebo	This group received dietary guidance and maltodextrin for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks	12 weeks	Defined as muscle mass (Unit: kg/m2)
Change from Baseline of grip strength at 12 weeks	12 weeks	Defined as muscle strength (Unit: kg)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of inflammation status at 12 weeks	12 weeks	Inflammation status will be represented by Interleukin-6 (IL-6), IL-8, IL-10 and Tumour necrosis factor alpha (TNF-α).
Change from Baseline of gut microbiota composition at 12 weeks	12 weeks	The stool samples of participants before and after intervention will be collected and analyzed by 16S ribosomal RNA (rRNA).
Change from Baseline of Short Physical Performance Battery score at 12 weeks	12 weeks	Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.
Change from Baseline of gait speed at 12 weeks	12 weeks	Defined as gait speed (Unit: m/s)
Change from Baseline of microbiota-derived metabolites at 12 weeks	12 weeks	Microbiota-derived metabolites includes short-chain fatty acids, amino acid metabolites and secondary bile acids.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China