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

NCT05919368 | Unknown DMC

• 1 other identifier: KFKT-2022-012
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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

Sarcopenia

Keywords

Traditional Chinese medicine; Intestinal flora；cognition

Outcome Measures

Primary Outcomes (1)

• Change from Baseline muscle mass at 6 months

  Double X-ray absorptiometry (DXA) was used to determine the skeletal mass (AMS) of the limbs of the patients. This method can accurately measure the total and local skeletal muscle mass, adipose tissue mass and bone mass, and calculate the muscle index = AMS/height 2 (kg/m2).

  baseline，After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up

Secondary Outcomes (6)

• Change from Baseline handgrip strength at 6 moths

  After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up

• Change from Baseline physical performance at 6 moths

  After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up

• Change from Baseline cognition at 6 moths

  After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up

• Change from Baseline 16s rRNA at 6 moths

  After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up

• Change from Baseline hemodynamics at 6 moths

  After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up

Study Arms (2)

Yam pill

EXPERIMENTAL

It consists of sweet potato, white art and ginseng

Dietary Supplement: Yam pill

placebo group

PLACEBO COMPARATOR

It consists of corn starch and dextrin

Dietary Supplement: Yam pill

Interventions

Yam pill DIETARY_SUPPLEMENT

It consists of sweet potato, white art and ginseng

Yam pill; placebo group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years old, in line with the AWGS diagnostic criteria for sarcopenia, and in line with the TCM dialectical standard of spleen deficiency syndrome;
• Be able to understand and cooperate with the test, and voluntarily sign the informed consent.

You may not qualify if:

• Motor dysfunction caused by severe nervous system diseases, musculoskeletal system diseases osteoporosis, severe osteoarthritis;
• severe heart, lung or mental illness, uncontrolled endocrine or metabolic disease, or severe liver or kidney function (such as cirrhosis, a history of kidney stones, kidney failure or dialysis);
• Inability to communicate properly with the researcher due to speech or uncorrected hearing impairment;
• Severe cognitive impairment (brief mental state examination: MMSE score \< 24 points), unable to understand the content included in the questionnaire and scale;
• Use of growth hormone, estrogen, progesterone or testosterone supplements for nearly 3 months, or severe nutritional deficiencies;
• Participate in other trials or Chinese medicine supplement trials in the past three months.

Sponsors & Collaborators

• Fujian University of Traditional Chinese Medicine: lead

Study Sites (1)

Suzhou Panomix biomedical tech Co., LTD

Suzhou, Jiangsu, 0202, China

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhizhen ZZ Liu

  Fujian University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lidian LD Chen

CONTACT

86+18120830559; 396389621@qq.com

Ruihan RH Wan

CONTACT

86+18751242707; wanruih@163.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: associate profession

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 26, 2023
• Study Start: September 12, 2023
• Primary Completion: September 15, 2023
• Study Completion: April 1, 2025
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)