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

NCT06347835 | Not Yet Recruiting

• 1 other identifier: Gut-Intervention-SAR-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Gut-muscle Axis; Biomarker; Gut microbiota; Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change from Baseline of Short Physical Performance Battery score at 12 weeks

  12 weeks

• Change from Baseline of gait speed at 12 weeks

  12 weeks

• Change from Baseline of gut microbiota composition at 12 weeks

  12 weeks

• Change from Baseline of inflammation status at 12 weeks

  12 weeks

• Change from Baseline of microbiota-derived metabolites at 12 weeks

  12 weeks

Study Arms (3)

symbiotic and whey protein intervention

EXPERIMENTAL

This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks

Dietary Supplement: symbiotic; Dietary Supplement: whey protein

whey protein intervention

EXPERIMENTAL

This group received dietary guidance and whey protein intervention for 12 weeks

Dietary Supplement: whey protein; Dietary Supplement: symbiotic placebo

control

PLACEBO COMPARATOR

This group received dietary guidance and maltodextrin for 12 weeks

Dietary Supplement: symbiotic placebo; Dietary Supplement: whey protein placebo

Interventions

symbiotic DIETARY_SUPPLEMENT

The intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification.

symbiotic and whey protein intervention

whey protein DIETARY_SUPPLEMENT

The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification.

symbiotic and whey protein intervention; whey protein intervention

symbiotic placebo DIETARY_SUPPLEMENT

The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.

control; whey protein intervention

whey protein placebo DIETARY_SUPPLEMENT

The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.

control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 and older
• Can cooperate with the measurement and questionnaire survey
• Meets Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria for sarcopenia
• Obtain informed consent to participate in this study

You may not qualify if:

• Severe complications
• Suffers from neuromuscular related diseases
• Immobility
• Have taken antibiotics, probiotics and other medications that may affect the gut microbiota in the last 6 weeks
• Implants of electronic devices or metal objects in the body

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Kang Yu, MD

CONTACT

+8613801130457; yuk1997@sina.com

Jiayu Guo, PhD

CONTACT

+8613719283691; guojy_7@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)