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Leucine Supplementation in Sarcopenic Older Individuals

NCT03831399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-04-06

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Leucine

Administration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks

DIETARY_SUPPLEMENT

Placebo

Administration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks

Sponsors & Collaborators

  • Armonea Group - La Saleta

    collaborator UNKNOWN

  • Bonusan BV

    collaborator UNKNOWN

  • University of Valencia

    lead OTHER

Principal Investigators

  • Omar Cauli, MD, PhD · Universitat de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2019-10-01
Completion
2019-10-14

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831399 on ClinicalTrials.gov