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临床试验/NCT03891134
NCT03891134已完成不适用

Associated Risk Factors and Effect of Nutritional Intervention for Sarcopenia and Constipation in Middle-Aged and Old People

Chimei Medical Center0 个研究点目标入组 630 人开始时间: 2016年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
630
主要终点
Handgrip

研究概览

简要总结

Sarcopenia is an age-related poor healthy outcome. nutrition intervention is one , progressive, generalized loss of muscle mass and the decrement in physical activity. Sarcopenia is associated with subsequent health hazards such as disability, falls, functional degeneration, hospitalization and death. There are similar causes between sarcopenia and constipation such as aging, reduced mobility, changes in diet and co-morbidities. Nutrition plays an important role for muscle maintenance. The trial tries to figure out the effect of enriched branched-chain amino acid (BCAA) nutrient on muscle mass, strength and physical performance of sarcopenia in the middle-aged and old people.

详细描述

Sarcopenia is the progressive loss of skeletal muscle that comes with aging. The population in the World Health Organization (WHO) is ageing rapidly and the proportion of people aged 65 and older will get forecast to increase 25% in 2050. In aging society, sarcopenia has been valued in countries all over the world. The appearance of sarcopenia is associated with decreased physical function, falls, fractures, disability, hospitalization, and poor quality of life. Constipation is a common healthy problem. Similar mechanism and risk factors between sarcopenia and constipation are observed with the association of nutrition, but the interrelationships between them is rarely studied.

Prevention and treatment of sarcopenia is more and more important in the health care. Exercise has positive effects in muscle mass and strength but frail elder can't perform exactly. In addition, dietary intervention is one of the major key to reduce the rate of muscle mass loss and maintain physical performance and function.

Recent studies have found that daily and/or supplemental protein is effective prevention of sarcopenia. Protein is composed of amino acids that can induce a muscle protein anabolic response conditioned by the availability of branched-chain amino acids (such as leucine, isoleucine, valine). Delayed amino acid absorption and anabolic resistance are frequently noted among elderly. Branched chain amino acid (BCAA) or leucine supplementation stimulates muscle protein synthesis.

The recommendation about nutrition for preventing sarcopenia was still inconsistent. The time of study for muscle parameter improvement varies from three days to seven days. At present, there is no consensus about the optimal type of nutritional supplements and hint of how long does nutrition take.

The aim of the present study is to evaluate the influence of enriched BCAA on those people with pre-sarcopenia or sarcopenia. The hypothesis is that subjects after enriched-BCAA supplement improves their physical function, muscle strength, and muscle mass. Subsequently, when dis-continued enriched-BCAA muscle-related outcomes would decline.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • over 40 years of age
  • generally healthy according to responses to a standard health-screening questionnaire.

排除标准

  • uncontrolled hypertension or diabetes
  • severe liver or renal disease
  • gastrointestinal disease
  • neuromuscular disease
  • infectious disease
  • pulmonary disease
  • disease of the endocrine system
  • history of seizures, neurological or significant psychiatric illness
  • sensitivity to study ingredients.

研究组 & 干预措施

enriched Branched Chain Amino Acid intervention

Experimental

enriched Branched Chain Amino Acid nutrition supplement 3.6 g twice a day for 5 weeks then withdrawal nutrition supplement for 12 weeks

干预措施: Branched Chain Amino Acid (Dietary Supplement)

结局指标

主要结局

Handgrip

时间窗: 17 weeks

Grip strength was measured by Grip-D; TKK 5401

Skeletal muscle mass index

时间窗: 17 weeks

Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)

6-meter gait speed

时间窗: 17 weeks

Measure walking speed of six meters

次要结局

未报告次要终点

研究者

发起方
Chimei Medical Center
申办方类型
Other
责任方
Sponsor

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