Frail Elderly SyndromePhase 1NCT03831399
Leucine Supplementation in Sarcopenic Older Individuals
A Phase 1 study testing Leucine in people with Frail Elderly Syndrome and Sarcopenia, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Sarcopenia
- What is being tested?
- Leucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 14 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical diagnosed severe dementia
- Severe psychiatric disease (i.e. schizophrenia)
- Glomerular filtrate <30 ml/min/1,73m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beneficial Effect of Leucine Supplementation in Muscular, Functional and Cognitive Functions 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.
- Conditions
- Frail Elderly Syndrome, Sarcopenia
- Being tested
- Leucine, Placebo
- Keywords
- Frailty, Aged, Leucine, Sarcopenia
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucineDietary supplement
Administration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks
PlaceboDietary supplement
Administration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 4 months
Secondary outcomes (26)
Cholesterol
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)
Measured: 4 months
Glucose
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)
Measured: 4 months
Creatinine
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)
Measured: 4 months
Triglycerides
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)
Measured: 4 months
IL-6
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)
Measured: 4 months
TNF-alfa
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)
Measured: 4 months
IGF-1
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)
Measured: 4 months
Leucine
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)
Measured: 4 months
Valine
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)
Measured: 4 months
Isoleucine
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)
Measured: 4 months
Glutamine
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)
Measured: 4 months
B-alanine
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)
Measured: 4 months
Albumine
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)
Measured: 4 months
Transthyretin
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)
Measured: 4 months
Myostatin
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)
Measured: 4 months
Body mass index
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:
Body mass index (kg/m2)
Measured: 4 months
Body perimeters
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:
Abdominal and calf perimeter (cm)
Measured: 4 months
Body composition
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)
Measured: 4 months
Comorbidities
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)
Measured: 4 months
Type and number of drugs used
Before starting and after finishing administration of Leucine supplement or placebo, the drugs consumed by each participant will be collected
Measured: 4 months
Gait and balance
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)
Measured: 4 months
Basic activities of daily living
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)
Measured: 4 months
Cognitive performance
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)
Measured: 4 months
Depression
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)
Measured: 4 months
Forced spirometry
Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as forced spirometry parameters (measured with a spirometer)
Measured: 4 months
Respiratory muscles strenght
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Oct 2019
- Study completion14 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study of phase I, pilot, prospective, multicentric, randomized, double blind and placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Armonea Group - La Saleta, Bonusan BV
- Responsible party
- Sponsor
- Investigators
- Omar Cauli, MD, PhD, Principal investigator, Universitat de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831399
- Sponsor's protocol ID
- H1524420647893
- Status last verified
- Jul 2019
- First submitted
- 9 Nov 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers
Publications
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.
PubMed 37887975Martinez-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.
PubMed 32230954
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effect of Leucine Supplementation in Muscular, Functional and Cognitive Functions in Sarcopenic Older Individuals
- ClinicalTrials.gov ID
- NCT03831399
- Acronym / sponsor ID
- H1524420647893
- Conditions
- Frail Elderly Syndrome, Sarcopenia
- Keywords
- Frailty, Aged, Leucine, Sarcopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Armonea Group - La Saleta, Bonusan BV
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Study of phase I, pilot, prospective, multicentric, randomized, double blind and placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Dietary Supplement: PlaceboSubjects 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. |
| Intervention Group | Active comparator | Dietary Supplement: LeucineSubjects 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Clinical diagnosed severe dementia
- Severe psychiatric disease (i.e. schizophrenia)
- Glomerular filtrate <30 ml/min/1,73m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeucineAdministration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks | Dietary supplement | Intervention Group |
| PlaceboAdministration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks | Dietary supplement | Control Group |
Primary outcome
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)
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)
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)
26 secondary outcomes
Cholesterol
Time frame: 4 months
Glucose
Time frame: 4 months
Creatinine
Time frame: 4 months
Triglycerides
Time frame: 4 months
IL-6
Time frame: 4 months
TNF-alfa
Time frame: 4 months
IGF-1
Time frame: 4 months
Leucine
Time frame: 4 months
Valine
Time frame: 4 months
Isoleucine
Time frame: 4 months
Glutamine
Time frame: 4 months
B-alanine
Time frame: 4 months
Albumine
Time frame: 4 months
Transthyretin
Time frame: 4 months
Myostatin
Time frame: 4 months
Body mass index
Time frame: 4 months
Body perimeters
Time frame: 4 months
Body composition
Time frame: 4 months
Comorbidities
Time frame: 4 months
Type and number of drugs used
Time frame: 4 months
Gait and balance
Time frame: 4 months
Basic activities of daily living
Time frame: 4 months
Cognitive performance
Time frame: 4 months
Depression
Time frame: 4 months
Forced spirometry
Time frame: 4 months
Respiratory muscles strenght
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Derived from this study: PubMed 37887975Buigues 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.
- Derived from this study: PubMed 32230954Martinez-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.
- Individual participant dataSharing planned: No. No data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Cauli, MD, PhD principal investigator
Universitat de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leucine in people with Frail Elderly Syndrome and Sarcopenia, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean mass (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03831399, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.