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

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

Interventions

DIETARY_SUPPLEMENT

Hirsutella Sinensis Nutrient Supplements

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

• Grape King Bio Ltd.

  collaborator INDUSTRY

• Chang Gung Memorial Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-15

Primary Completion

2024-02-15

Completion

2024-02-15

Countries

• Taiwan

Study Locations