Clinical trial NCT06347835: Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis
Official title: Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Gut-muscle Axis
Biomarker
Gut microbiota
Intervention
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline of grip strength at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from Baseline of Short Physical Performance Battery score at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline of gait speed at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline of gut microbiota composition at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline of inflammation status at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline of microbiota-derived metabolites at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: