Leucine Supplementation in Sarcopenic Older Individuals

NCT03831399 | Completed Phase 1

• 1 other identifier: H1524420647893
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Keywords

Frailty; Aged; Leucine; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (26)

• Cholesterol

  4 months

• Glucose

  4 months

• Creatinine

  4 months

• Triglycerides

  4 months

• IL-6

  4 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Intervention Group

ACTIVE COMPARATOR

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.

Dietary Supplement: Leucine

Interventions

Leucine DIETARY_SUPPLEMENT

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

Intervention Group

Placebo DIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clinical diagnosed severe dementia
• Severe psychiatric disease (i.e. schizophrenia)
• Glomerular filtrate \<30 ml/min/1,73m2

Sponsors & Collaborators

• University of Valencia: lead
• Armonea Group - La Saleta: collaborator
• Bonusan BV: collaborator

Study Sites (1)

University of Valencia

Valencia, Spain

Location

Related Publications (2)

• 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.

  PMID: 37887975 DERIVED

• 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.

  PMID: 32230954 DERIVED

MeSH Terms

Conditions

Sarcopenia; Frailty

Interventions

Leucine

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Omar Cauli, MD, PhD

  Universitat de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Administration of Leucine or placebo (microcrystalline cellulose) will be done twice/day in the morning and in the afternoon for 13 weeks measuring spoon of placebo. Both products will be delivered in white jars, without label, and will carry the patient number on the outside. Randomization of numbers to either placebo or verum product will take place by Bonusan and will be revealed to the researchers at the end of final phase. The administration of prebiotics or placebo will last 13 weeks except for appearance of side-effects related to the study. The side-effects will be recorded and consulted with Bonusan Research Staff. The researcher enrolled in the geriatric, psychological or analytical measurements will be blind to the drug treatment. After finishing the study period, the study the Director of the Research group (Dr. Omar Cauli) will ask Bonusan to reveal who participants received Leucine and those who received placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study of phase I, pilot, prospective, multicentric, randomized, double blind and placebo-controlled

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: February 5, 2019
• Study Start: February 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 14, 2019
• Last Updated: April 6, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)