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Completed

NCT Number: NCT03831399

Leucine Supplementation in Sarcopenic Older Individuals

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.

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Key information

Conditions

Frail Elderly Syndrome Atrophy Frailty Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Valencia

Valencia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leucine

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Lean mass

    Time frame: 4 months

    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)

  2. Strength

    Time frame: 4 months

    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)

  3. Physical performance

    Time frame: 4 months

    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)

Secondary outcomes

  1. Cholesterol

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine total, HDL and LDL cholesterol (mg/dL)

  2. Glucose

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine glucose (mg/dL)

  3. Creatinine

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine creatinine (mg/dL)

  4. Triglycerides

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine triglycerides (mg/dL)

  5. IL-6

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:

    IL6 (pg/mL)

  6. TNF-alfa

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:

    TNF-alfa (pg/mL)

  7. IGF-1

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:

    IGF-1 (mg/mL)

  8. Leucine

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as leucine concentration (mg/mL)

  9. Valine

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as valine concentration (mg/mL)

  10. Isoleucine

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as isoleucine concentration (mg/mL)

  11. Glutamine

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as glutamine concentration (mg/mL)

  12. B-alanine

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as B-alanine concentration (mg/mL)

  13. Albumine

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:

    albumine (g/L)

  14. Transthyretin

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:

    transthyretin (mg/L)

  15. Myostatin

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:

    myostatin (ng/mL)

  16. Body mass index

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:

    Body mass index (kg/m2)

  17. Body perimeters

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:

    Abdominal and calf perimeter (cm)

  18. Body composition

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as bioimpedance to know fat and lean mass (kg)

  19. Comorbidities

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as Charlson index score (absence of comorbidity: 0-1 points, low comorbidity: 2 points, and high comorbidity > 3 points)

  20. Type and number of drugs used

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, the drugs consumed by each participant will be collected

  21. Gait and balance

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Tinetti index Scale(0 to 28 points, 19-24 risk of falling, <19 high risk of falling)

  22. Basic activities of daily living

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Barthel index Scale to measure the activities of daily living and mobility (o to 100 points, < 60 dependence)

  23. Cognitive performance

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Mini-mental score examination Scale (MMSE - 0 to 30 points, <24 points cognitive impairment, <21 mild cognitive impairment)

  24. Depression

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Yesavage Scale for geriatric depression (0 to 15 points, >5 points high risk of depression)

  25. Forced spirometry

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as forced spirometry parameters (measured with a spirometer)

  26. Respiratory muscles strenght

    Time frame: 4 months

    Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as maximal respiratory pressures (measured with a respiratory pressure gauge)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Armonea Group - La Saleta
  • Bonusan BV

Registry information

Official study title

Beneficial Effect of Leucine Supplementation in Muscular, Functional and Cognitive Functions in Sarcopenic Older Individuals

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2019
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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