Leucine Supplementation in Sarcopenic Older Individuals

Study Overview
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Brief Summary
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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.

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

Conditions
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Frail Elderly Syndrome, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Leucine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Clinical diagnosed severe dementia Severe psychiatric disease (i.e. schizophrenia) Glomerular filtrate <30 ml/min/1,73m2

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study of phase I, pilot, prospective, multicentric, randomized, double blind and placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Subjects in control group will receive placebo (lactose) 6g/day in two doses, in two spoon at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks. The product will be delivered in powder, in white jars, without label, and will only carry the patient number on the outside, 4 jars per participant. | Dietary Supplement: Placebo<br>* Administration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks<br>|
| Active Comparator: Intervention Group<br>Subjects in intervention group will receive leucine 6g/day, in tin two doses, in two spoon at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks. The product will be delivered in powder, in white jars, without label, and will only carry the patient number on the outside, 4 jars per participant. | Dietary Supplement: Leucine<br>* Administration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Aged, Leucine, Sarcopenia