Leucine Supplementation in Sarcopenic Older Individuals

NCT ID: NCT03831399

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-10-14

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.

Conditions

Frail Elderly Syndrome; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Group

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.

Group Type: ACTIVE_COMPARATOR

Leucine

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Leucine

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armonea Group - La Saleta

UNKNOWN

Sponsor Role: collaborator

Bonusan BV

UNKNOWN

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omar Cauli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Valencia

Locations

University of Valencia

Valencia, , Spain

Countries

Spain

References

Buigues C, Theou O, Fonfria-Vivas R, Martinez-Arnau FM, Rockwood K, Cauli O. Can Leucine Supplementation Improve Frailty Index Scores? Geriatrics (Basel). 2023 Oct 12;8(5):102. doi: 10.3390/geriatrics8050102.

Reference Type: DERIVED

PMID: 37887975 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32230954 (View on PubMed)

Other Identifiers

H1524420647893

Identifier Type: -

Identifier Source: org_study_id