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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06347835
Other study ID # Gut-Intervention-SAR-2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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