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The Shape Regulation Mechanism of Yam Pill on Patients With Sarcopenia Based on Intestine-muscle-brain Axis

NCT05919368 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-09-14

No results posted yet for this study

Summary

The main manifestation of sarcopenia is the decline of muscle strength, quality, and physical function, and it has the characteristics of overlapping, changing, or transforming with cognitive and emotional problems， belonging to the category of physical and mental diseases. At present, the effective treatment and mechanism of the disease are still unclear. The team's preliminary study found that the Jingfang Yam pill has unique advantages in "spleen dominates muscle", which can significantly improve the skeletal muscle mass, strength, and endurance of mice. The intestine-muscle-brain axis-spleen deficiency may be the key pathogenesis of sarcopenia. As such, the study proposes a hypothesis: whether Yam pills intervene in patients with sarcopenia is achieved bidirectional balance regulation of the body through the bidirectional communication pathway of the muscle-brain axis regulated by the intestinal flora. This project applies a randomized, placebo-controlled, double-blind RCT study design, with sarcopenia patients as the research objects, and utilizes musculoskeletal ultrasound, gut microbiota, untargeted metabolomics, functional near-infrared imaging, and other multidisciplinary techniques. To explore the mechanism of Yam pill regulating patients with sarcopenia by regulating intestinal microecology and metabolism-related molecules mediated by the "intestine-muscle-brain axis".

Conditions

Interventions

DIETARY_SUPPLEMENT

Yam pill

It consists of sweet potato, white art and ginseng

Sponsors & Collaborators

  • Fujian University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Zhizhen ZZ Liu · Fujian University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2023-09-15
Completion
2025-04-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919368 on ClinicalTrials.gov