跳至主要内容
临床试验/NCT05284149
NCT05284149Unknown不适用

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

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
The effect of Hirsutella sinensis nutrient supplements had on muscle health

研究概览

简要总结

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.

详细描述

In 1988, Irwin Rosenberg first proposed the term "Sarcopenia" for sarcopenia, which refers to the amount of muscle loss with age. In 2007, the European Working Group on Sarcopenia in Older People (EWGSOP) reached a consensus of three criteria for aging-related sarcopenia: reduced muscle mass after 65 years of age (60 or 65 years according to the criteria set by each country), weakening of muscle strength (using grip strength), and physiological performance (using walking speed)

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, there is now considerable evidence that muscle and bone have common genetic, nutritional, lifestyle, and hormonal determinants. Besides, muscle and bone interact with each other to impact bone strength. A possible mechanism is the dynamic loading arises from muscle contractions and the ground impact during weight-bearing activities. In 2009, the term "sarco-osteopenia" was coined to emphasize that both weak bones and weak muscles may contribute to fractures in the elderly. Therefore, treatments related to increasing muscle mass are essential for the elderly to reduce adverse clinical outcomes such as falls and fractures. At present, the most efficient treatment is adequate nutrient intake.

The elderly often encountered malnutrition due to inadequate nutrient intake and scarce nutrient diversity. While malnutrition is often one of the leading causes of sarcopenia. Therefore, effective nutritional supplementation is essential for the elderly. Efficient nutrient supply will improve the symptoms of sarcopenia patients and improve the quality of life. As Taiwan gradually enters the advanced age society, sarcopenia in the elderly is inevitable. Preventing and treating aging-related muscle loss is becoming a crucial issue that everyone must face. However, there is still a scarcely known nutrient supplement that effectively improves muscle health in the elderly. Moreover, to increase the wiliness of the elderly in taking nutrient supplements, the nutrient supplements must be safe and easily assessable nutrient supplement and do not require a physician prescription. In the Asian population, elderlies incline to Chinese medicine supplements.

Cordyceps sinensis is a well-known valuable traditional Chinese medicine. It is the fungi-insect complex from Clavicipitacease and Cordyceps sinensis (Berk.) Sacc. parasitic on the Heptaidae insects' larvae. Cordyceps sinensis are mainly distributed in the high-mountain areas like Tibet, Sichuan, Qinghai, and Gansu. The traditional Chinese medicine of Cordyceps sinensis have recorded its beneficial effects in kidney and lung, replenishing essence, cough relief and reducing sputum. In the 1990s, a group of female marathon runners led by Mr. Ma Jun-ren, commonly known as Ma family army, trained several world-class middle- and long-distance runner which broke 66 domestic and international records in many competitions. There has been suggestion of his secret performance-enhancing recipe, which includes the combination of Cordyceps, turtle essence and other healthcare products to the athletes' diet. This recipe sets off the Cordyceps market demand once more in China. Enormous Cordyceps were harvested and sold at the same time for research and development. The price of naturally found cordyceps become so scarce that the end-price is almost equivalent to the gold. At the same time period, a total of 22 asexual strains involving 13 genera were isolated from the Cordyceps fruiting bodies collected from different regions. Molecular identification of rDNA ITS region and RAPD molecular markers from the fruiting bodies were detailly compared to finally confirmed that Hirsutella sinensis was an asexual strain of Cordyceps sinensis.

Researchers have found that Hirsutella sinensis has many benefits in anti-inflammatory, anti-liver cancer activity, reduces tetrachloride damage, immune regulation, improves Bleomycin-induced lung fibrosis, aristolochic acid or cisplatin induced Kidney damage... and more. More importantly, study 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be eligible for inclusion, each participant must fulfill all of the following criteria:
  • 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

排除标准

  • 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

结局指标

主要结局

The effect of Hirsutella sinensis nutrient supplements had on muscle health

时间窗: 1 year

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

Metabolite alternations of Hirsutella Sinensis on muscle health

时间窗: 1 year

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)

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Hsiang Juan

Associate Professor

Chang Gung Memorial Hospital

研究点 (2)

Loading locations...

相似试验