Leucine Supplementation in Sarcopenic Older Individuals

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831399
• Other study ID #: H1524420647893
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2019
• Est. completion date: October 14, 2019

Study information

• Verified date: July 2019
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 14, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Sarcopenia

Intervention

Dietary Supplement:
• Leucine
Administration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks
• Placebo
Administration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
University of Valencia	Armonea Group - La Saleta, Bonusan BV

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Link to the main article published in Nutrients, March 2020