Clinical trial NCT03831399: Leucine Supplementation in Sarcopenic Older Individuals
Official title: Beneficial Effect of Leucine Supplementation in Muscular, Functional and Cognitive Functions in Sarcopenic Older Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Frail Elderly Syndrome
Sarcopenia
Keywords: Frailty
Aged
Leucine
Sarcopenia
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Armonea Group - La Saleta
name: Bonusan BV
First posted: 2019-02-05
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study of phase I, pilot, prospective, multicentric, randomized, double blind and placebo-controlled
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Lean mass
timeFrame: 4 months
measure: Strength
timeFrame: 4 months
measure: Physical performance
timeFrame: 4 months
Secondary outcomes:
measure: Cholesterol
timeFrame: 4 months
measure: Glucose
timeFrame: 4 months
measure: Creatinine
timeFrame: 4 months
measure: Triglycerides
timeFrame: 4 months
measure: IL-6
timeFrame: 4 months
measure: TNF-alfa
timeFrame: 4 months
measure: IGF-1
timeFrame: 4 months
measure: Leucine
timeFrame: 4 months
measure: Valine
timeFrame: 4 months
measure: Isoleucine
timeFrame: 4 months
measure: Glutamine
timeFrame: 4 months
measure: B-alanine
timeFrame: 4 months
measure: Albumine
timeFrame: 4 months
measure: Transthyretin
timeFrame: 4 months
measure: Myostatin
timeFrame: 4 months
measure: Body mass index
timeFrame: 4 months
measure: Body perimeters
timeFrame: 4 months
measure: Body composition
timeFrame: 4 months
measure: Comorbidities
timeFrame: 4 months
measure: Type and number of drugs used
timeFrame: 4 months
measure: Gait and balance
timeFrame: 4 months
measure: Basic activities of daily living
timeFrame: 4 months
measure: Cognitive performance
timeFrame: 4 months
measure: Depression
timeFrame: 4 months
measure: Forced spirometry
timeFrame: 4 months
measure: Respiratory muscles strenght
timeFrame: 4 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Universitat de Valencia
name: Omar Cauli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Arnau FM, Fonfria-Vivas R, Buigues C, Castillo Y, Molina P, Hoogland AJ, van Doesburg F, Pruimboom L, Fernandez-Garrido J, Cauli O. Effects of Leucine Administration in Sarcopenia: A Randomized and Placebo-controlled Clinical Trial. Nutrients. 2020 Mar 27;12(4):932. doi: 10.3390/nu12040932.