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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347835
• Other study ID #: Gut-Intervention-SAR-2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu, MD
• Phone: +8613801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• symbiotic
The intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification.
• whey protein
The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification.
• symbiotic placebo
The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.
• whey protein placebo
The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks	Defined as muscle mass (Unit: kg/m2)	12 weeks
Primary	Change from Baseline of grip strength at 12 weeks	Defined as muscle strength (Unit: kg)	12 weeks
Secondary	Change from Baseline of Short Physical Performance Battery score at 12 weeks	Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.	12 weeks
Secondary	Change from Baseline of gait speed at 12 weeks	Defined as gait speed (Unit: m/s)	12 weeks
Secondary	Change from Baseline of gut microbiota composition at 12 weeks	The stool samples of participants before and after intervention will be collected and analyzed by 16S ribosomal RNA (rRNA).	12 weeks
Secondary	Change from Baseline of inflammation status at 12 weeks	Inflammation status will be represented by Interleukin-6 (IL-6), IL-8, IL-10 and Tumour necrosis factor alpha (TNF-a).	12 weeks
Secondary	Change from Baseline of microbiota-derived metabolites at 12 weeks	Microbiota-derived metabolites includes short-chain fatty acids, amino acid metabolites and secondary bile acids.	12 weeks