Study the Impact of Hirsutella Sinensis Nutrient Supplements Has on Improving Muscle Health and Metabolism in Elderly

NCT05284149 | Unknown

• 1 other identifier: 202100881A3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia has now been officially recognized as a muscle disease related to aging, which may increase the risk of falls and fractures and both heart and respiratory diseases in the elderly. Sarcopenia causes inconvenience in the elderly, affecting their quality of life and often requiring long-term care or even resulting in death. Moreover, the elderly often encountered malnutrition due to inadequate nutrient intake and scarce nutrient diversity. Furthermore, malnutrition is often one of the leading causes of sarcopenia. Therefore, effective nutritional supplementation is essential to improve or prevent muscle loss for the elderly. Cordyceps sinensis is a well-known valuable traditional Chinese medicine and Hirsutella sinensis was an asexual strain of Cordyceps sinensis. Researchers have found that Hirsutella sinensis can help to increase connection between gastrocnemius muscle fibers and spinal nerve under the amyotrophic lateral sclerosis animal disease model. However, culturing conditions for Hirsutella sinensis are extremely difficult and long, one of the key culturing condition is the temperature, must be maintaining at 16-20℃for 45 days. Fortunately, Grape King Biotech has core technology using liquid fermentation which greatly shortened the cultivation time, thus, providing sufficient and safe products to patients. The investigators designed a randomized placebo-controlled study first to investigate the relationship and clinical impact Hirsutella Sinensis had on muscle mass and function in the elderly. Second, investigate the metabolic impact Hirsutella Sinensis had on muscle mass.

Conditions

Sarcopenia; Old Age; Debility; Muscle Loss

Outcome Measures

Primary Outcomes (2)

• The effect of Hirsutella sinensis nutrient supplements had on muscle health

  The change in muscle mass (in grams) as assessed by dual-energy fan-beam X-ray absorptiometry.

  1 year

• Metabolite alternations of Hirsutella Sinensis on muscle health

  The changes in major metabolite pathways as assessed (such as amino acids, lipids, in m/z) using the metabolomic liquid chromatography coupled to mass. spectrometry (LC-MS)

  1 year

Study Arms (2)

H.S. Supplement

ACTIVE COMPARATOR

Patients taking Hirsutella Sinensis Nutrient Supplements

Dietary Supplement: Hirsutella Sinensis Nutrient Supplements

Placebo

PLACEBO COMPARATOR

Patients taking placebo

Dietary Supplement: Placebo

Interventions

Hirsutella Sinensis Nutrient Supplements DIETARY_SUPPLEMENT

This randomized control study will be conducted in 2 years. We expect to recruit 50 participants with age ≥ 50 years old. Enrolled participants will be recruited into Hirsutella Sinensis nutrient supplement group (50 patients H.S. suppl.) . The medication will be given to the participants by a third party. All participants will have two different follow-up periods (6, 12 months). These follow-ups included clinical, laboratory, and imaging studies to analyze muscle health changes after receiving Hirsutella Sinensis nutrient supplement.

H.S. Supplement

Placebo DIETARY_SUPPLEMENT

We expect to recruit 50 placebo participants with age ≥ 50 years old. This randomized control study will be conducted in 2 years. The placebo will be given to the participants by a third party. All participants will have two different follow-up periods (6, 12 months). These follow-ups included clinical, laboratory, and imaging studies to analyze muscle health changes after receiving placebo.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>50 years old.
• Negative pregnancy test for women of childbearing potential.
• Ability to understand and willingness to be enrolled in our study and sign a written informed consent document

You may not qualify if:

• Participant who has any of the following criteria will be excluded from the trial:
• Physical or mental inability.
• Body mass index (BMI) \> 35 kg/m2
• Participants have acute medical conditions (such as bacterial or viral infection or active cardiopulmonary disease) that may be incapable of having regular image study.
• Participants are under regular steroid or hyperthyroid medications, which may have great impact on the whole-body metabolism.
• Participants are under-nutrient, and they need to have regular liquid oral nutrition formulas support.
• Participants not expecting to comply with follow up.
• Received barium study within a week
• Participants allergic or unable ingest Hirsutella Sinensis nutrient supplement

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Grape King Bio Ltd.: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Keelung Branch

Keelung, 204, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Frailty; Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yu-Ching Lin, MD

CONTACT

+886-975366386; yuching1221@gmail.com

Yu-Hsiang Juan, MD

CONTACT

+886-975366388; Jonat126@yahoo.com.tw

Study Design

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

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: March 17, 2022
• Study Start: February 15, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)