Sarcopenia
Conditions
Keywords
Sarcopenia, Gut-muscle Axis, Biomarker, Gut microbiota, Intervention
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.
Interventions
DIETARY_SUPPLEMENTsymbiotic
The intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification.
DIETARY_SUPPLEMENTwhey protein
The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification.
DIETARY_SUPPLEMENTsymbiotic placebo
The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.
DIETARY_SUPPLEMENTwhey protein placebo
The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 microbiota-derived metabolites at 12 weeks | 12 weeks | Microbiota-derived metabolites includes short-chain fatty acids, amino acid metabolites and secondary bile acids. |
| 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 gait speed at 12 weeks | 12 weeks | Defined as gait speed (Unit: m/s) |
Countries
China
Contacts
Primary ContactKang Yu, MD
Backup ContactJiayu Guo, PhD
Outcome results
None listed