跳至主要内容
临床试验/NCT05917353
NCT05917353招募中不适用

A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Change from Baseline Appendicular skeletal muscle mass index at 8 weeks

研究概览

简要总结

Taiwan is about to enter a super-aged society in 2025. The health problems of the elderly are getting more and more attention. Among these geriatric issues, sarcopenia is an important issue. Sarcopenia is the culprit of disability in old age. It is characterized by persistent and general loss of skeletal muscle mass and function throughout the body, which may lead to disability, decreased quality of life, and even inability to take care of yourself and an increased risk of death. Human skeletal muscle decreases with age. After the age of 40, muscle mass will be lost at a rate of 8% per decade; after the age of 70, it will be lost at a faster rate of 15% per decade in average. Although all elderly will lose muscle mass due to aging, the degree and speed of loss vary from person to person. In addition to aging, it may also be caused by chronic diseases.

Exercise intervention and nutritional intervention are the first choices for sarcopenia intervention. Regarding nutritional requirements, the elderly need at least 15 grams of essential amino acids per day for muscle building. Among them, leucine is the most important, which can increase protein production and reduce decomposition. Foods rich in leucine include soybeans, fish or beef. However, elderly people may not be able to get enough protein from their daily diet smoothly, often because of dysphagia, such as dental problems or chewing and swallowing problems. Therefore, oral nutritional supplements are relatively important for the improvement of muscle mass. Nutritional Supplement Hinex Jelly has 303 calories per serving, contains up to 15g of high-quality protein and a high amount of branched-chain amino acids, which is beneficial for muscle synthesis and tissue repair, plus a variety of minerals, vitamins, water-soluble dietary fiber, hydrolyzed collagen and other ingredients can strengthen nutritional supplements, maintain good health.

In summary, this study intends to explore the effect of Hinex Jelly nutritional supplemental intervention on muscle mass quality and quantity changes by means of randomized intervention and controlled trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (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

  • Adults over the age of 50 (include 50 years old).
  • Can cooperate with the study.
  • No surgical intervention within 3 months.

排除标准

  • Those who have obvious difficulty in movement (such as amputation) and cannot cooperate with the study.
  • Those who are equipped with pacemakers or internal electronic medical devices.
  • Pregnant women.
  • Use of drugs or interventional therapy that may affect changes in body weight or muscle mass (such as other oral nutritional supplements, medicine, weight reduction medicine, bariatric gastric endoscopy therapy, bariatric surgery, acupuncture, acupuncture, electrical stimulation, etc.).
  • Allergic to dairy or soy products.

结局指标

主要结局

Change from Baseline Appendicular skeletal muscle mass index at 8 weeks

时间窗: 8 weeks after the first session

Appendicular skeletal muscle mass index assessed using the Inbody S10

Change from Baseline performance on the 5-repetition sit-to-stand test at 8 weeks

时间窗: 8 weeks after the first session

assessed in seconds

Change from Baseline performance on 6-metre walk test at 8 weeks

时间窗: 8 weeks after the first session

assessed in seconds

Change from Baseline handgrip strength at 8 weeks

时间窗: 8 weeks after the first session

assessed with a Jamar handheld dynamometer in kilograms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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