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

NCT06347835 — Not applicable, Unknown, 120 participants, Peking Union Medical College Hospital

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Registry	NCT06347835
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	120 (Estimated)
Sponsor	Peking Union Medical College Hospital (Other)
Conditions	Sarcopenia
Interventions	symbiotic, whey protein, symbiotic placebo, whey protein placebo (Dietary supplement)
Dates	start 2024-04-01 (estimated), primary completion 2025-04-01 (estimated), completion 2026-01-01 (estimated), first posted 2024-04-04, last updated 2024-04-22
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
symbiotic and whey protein intervention	Experimental	Dietary Supplement: symbiotic; Dietary Supplement: whey protein	This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks
whey protein intervention	Experimental	Dietary Supplement: whey protein; Dietary Supplement: symbiotic placebo	This group received dietary guidance and whey protein intervention for 12 weeks
control	Placebo comparator	Dietary Supplement: symbiotic placebo; Dietary Supplement: whey protein placebo	This group received dietary guidance and maltodextrin for 12 weeks

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

+Outcome measures

Primary outcomes

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 outcomes

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 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 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 microbiota-derived metabolites at 12 weeks [12 weeks]: Microbiota-derived metabolites includes short-chain fatty acids, amino acid metabolites and secondary bile acids.

+Eligibility

Sex: All, ages: 65 Years to any

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

+Locations (1)

Facility	City	Country	Status
Peking Union Medical College Hospital	Beijing, Beijing Municipality	China