Leucine Supplementation in Sarcopenic Older Individuals

University of Valencia

Status and phase: Completed; Phase 1

Conditions: Sarcopenia; Frail Elderly Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Leucine

Study type: Interventional

Funder types: Other

Identifiers

NCT03831399

H1524420647893

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Intervention Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Leucine