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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: symbiotic; Dietary supplement: whey protein; Dietary supplement: symbiotic placebo; Dietary supplement: whey protein placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kang Yu, MD; Phone Number: +8613801130457; Email: yuk1997@sina.com
• Study Contact Backup: Name: Jiayu Guo, PhD; Phone Number: +8613719283691; Email: guojy_7@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
      • Contact: Kang Yu, MD; Phone Number: +86 010-69155550; Email: yuk1997@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: symbiotic and whey protein intervention; This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks	Dietary supplement: symbiotic; The intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification.; Dietary supplement: whey protein; The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification.
Experimental: whey protein intervention; This group received dietary guidance and whey protein intervention for 12 weeks	Dietary supplement: whey protein; The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification.; Dietary supplement: symbiotic placebo; The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.
Placebo Comparator: control; This group received dietary guidance and maltodextrin for 12 weeks	Dietary supplement: symbiotic placebo; The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.; Dietary supplement: whey protein placebo; The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks	Defined as muscle mass (Unit: kg/m2)	12 weeks
Change from Baseline of grip strength at 12 weeks	Defined as muscle strength (Unit: kg)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from Baseline of gait speed at 12 weeks	Defined as gait speed (Unit: m/s)	12 weeks
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
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
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-α).	12 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Biomarker; Sarcopenia; Intervention; Gut microbiota; Gut-muscle Axis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: Gut-Intervention-SAR-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No