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临床试验/NCT03831399
NCT03831399已完成1 期

Beneficial Effect of Leucine Supplementation in Muscular, Functional and Cognitive Functions in Sarcopenic Older Individuals

University of Valencia1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
59
试验地点
1
主要终点
Lean mass

研究概览

简要总结

Caring with older people in west societies has becoming a challenge for all health professional and any measure that can increase health or well-being will be ultimately improve quality of life and life expectancy. Frailty is a geriatric syndrome describing physical and functional decline that occurs as a consequence of certain diseases (e.g., cancer, chronic infection, etc.) but also even without disease. Frailty is characterized by an increased risk for poor outcomes such as incident falls, fractures, disability, comorbidity, health care expenditure and premature mortality. The aetiology of frailty is not well understood but it has been associated with changes in several physiologic systems, including inflammation, metabolic and micronutrients deficits.

The investigators wish to test with a confident perspective that any measured that improve the efficiency of muscular system can prevent the progression of frailty syndrome and that can have many others effects since it has been consistently demonstrated that a proper muscular function in aging is associated with other signs and symptoms. Looking at the literature, there are two clinical trials that evaluated the effect of leucine supplementation in older individuals with beneficial effects. The investigators wish to replicate those findings and to extend the analysis of the effect afforded by leucine supplementation in sarcopenia, frailty and cognitive function in individuals living in nursing homes in Valencia and province. This trial will show the eventual effects of leucine supplementation in elderly people may be also useful to afford some beneficial effects (sleep, cognitive function, depressed mood, balance and gait, etc) by modulating the function of muscular and metabolic system and in reduce the progression of sarcopenia and loss of muscular function.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Administration of Leucine or placebo (microcrystalline cellulose) will be done twice/day in the morning and in the afternoon for 13 weeks measuring spoon of placebo. Both products will be delivered in white jars, without label, and will carry the patient number on the outside. Randomization of numbers to either placebo or verum product will take place by Bonusan and will be revealed to the researchers at the end of final phase.

The administration of prebiotics or placebo will last 13 weeks except for appearance of side-effects related to the study. The side-effects will be recorded and consulted with Bonusan Research Staff.

The researcher enrolled in the geriatric, psychological or analytical measurements will be blind to the drug treatment.

After finishing the study period, the study the Director of the Research group (Dr. Omar Cauli) will ask Bonusan to reveal who participants received Leucine and those who received placebo.

入排标准

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

入选标准

  • Ability to walk alone or with help of a can or a walker
  • Age 60 years or older
  • Cognitive function equal or higher than 21points in Mini-mental examination score
  • Both genders
  • Institutionalized in nursing homes for at least 6 months

排除标准

  • Clinical diagnosed severe dementia
  • Severe psychiatric disease (i.e. schizophrenia)
  • Glomerular filtrate <30 ml/min/1,73m2

结局指标

主要结局

Lean mass

时间窗: 4 months

Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria: Skeletal muscle mass index (kg/m2)

Strength

时间窗: 4 months

Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria: Handgrip Strength (kg)

Physical performance

时间窗: 4 months

Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria: Walking speed (m/s)

次要结局

  • Cholesterol(4 months)
  • Glucose(4 months)
  • Isoleucine(4 months)
  • Creatinine(4 months)
  • Triglycerides(4 months)
  • IL-6(4 months)
  • TNF-alfa(4 months)
  • IGF-1(4 months)
  • Leucine(4 months)
  • Valine(4 months)
  • Glutamine(4 months)
  • B-alanine(4 months)
  • Albumine(4 months)
  • Transthyretin(4 months)
  • Myostatin(4 months)
  • Body mass index(4 months)
  • Body perimeters(4 months)
  • Body composition(4 months)
  • Comorbidities(4 months)
  • Type and number of drugs used(4 months)
  • Gait and balance(4 months)
  • Basic activities of daily living(4 months)
  • Cognitive performance(4 months)
  • Depression(4 months)
  • Forced spirometry(4 months)
  • Respiratory muscles strenght(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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