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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
59
University of Valencia
Valencia, Spain
Lean mass
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)
Time frame: 4 months
Strength
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)
Time frame: 4 months
Physical performance
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)
Time frame: 4 months
Cholesterol
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine total, HDL and LDL cholesterol (mg/dL)
Time frame: 4 months
Glucose
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine glucose (mg/dL)
Time frame: 4 months
Creatinine
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine creatinine (mg/dL)
Time frame: 4 months
Triglycerides
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine triglycerides (mg/dL)
Time frame: 4 months
IL-6
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as: IL6 (pg/mL)
Time frame: 4 months
TNF-alfa
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as: TNF-alfa (pg/mL)
Time frame: 4 months
IGF-1
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as: IGF-1 (mg/mL)
Time frame: 4 months
Leucine
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as leucine concentration (mg/mL)
Time frame: 4 months
Valine
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as valine concentration (mg/mL)
Time frame: 4 months
Isoleucine
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as isoleucine concentration (mg/mL)
Time frame: 4 months
Glutamine
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as glutamine concentration (mg/mL)
Time frame: 4 months
B-alanine
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as B-alanine concentration (mg/mL)
Time frame: 4 months
Albumine
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as: albumine (g/L)
Time frame: 4 months
Transthyretin
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as: transthyretin (mg/L)
Time frame: 4 months
Myostatin
Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as: myostatin (ng/mL)
Time frame: 4 months
Body mass index
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as: Body mass index (kg/m2)
Time frame: 4 months
Body perimeters
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as: Abdominal and calf perimeter (cm)
Time frame: 4 months
Body composition
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as bioimpedance to know fat and lean mass (kg)
Time frame: 4 months
Comorbidities
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as Charlson index score (absence of comorbidity: 0-1 points, low comorbidity: 2 points, and high comorbidity \> 3 points)
Time frame: 4 months
Type and number of drugs used
Before starting and after finishing administration of Leucine supplement or placebo, the drugs consumed by each participant will be collected
Time frame: 4 months
Gait and balance
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Tinetti index Scale(0 to 28 points, 19-24 risk of falling, \<19 high risk of falling)
Time frame: 4 months
Basic activities of daily living
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Barthel index Scale to measure the activities of daily living and mobility (o to 100 points, \< 60 dependence)
Time frame: 4 months
Cognitive performance
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Mini-mental score examination Scale (MMSE - 0 to 30 points, \<24 points cognitive impairment, \<21 mild cognitive impairment)
Time frame: 4 months
Depression
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Yesavage Scale for geriatric depression (0 to 15 points, \>5 points high risk of depression)
Time frame: 4 months
Forced spirometry
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as forced spirometry parameters (measured with a spirometer)
Time frame: 4 months
Respiratory muscles strenght
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as maximal respiratory pressures (measured with a respiratory pressure gauge)
Time frame: 4 months
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