Carnitine; MusclePhase 2/3NCT03180424
Impact on Functional Status in Older Adults Treated With L-Carnitine
A Phase 2/3 study testing L Carnitine, Supervised exercise and Exercise at home in people with Carnitine; Muscle and Functional Status, run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.
Trial summary
This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical exercise at home or supervised. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carnitine; Muscle, Functional Status, Old Age; Debility
- What is being tested?
- L Carnitine, Supervised exercise and Exercise at home
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUruguay
- Study dates
- 1 Jan 2017to 30 Sep 2017
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients who meet at least 2 criteria for the fragility phenotype of Linda Fried
- Ability to comply with aerobic physical activity of moderate intensity and basic resistance.
- Not depressed patients (Yesavage <5 in patients without previous depression or Hamilton <7 in patients in treatment for depression)
- MMSE (Mini-Mental State Examination) greater than 24 points.
- Independent or mildly dependent patients, Barthel> 95 points.
- Patients without visual disturbances or with decreased visual acuity corrected.
- No pain or with VAS (Visual analogue scale) <3/10.
- Patients without nutritional risk, MNA (Mini Nutritional Assessment > 23.5 / 30 points) and BMI (Body Mass Index) > 23 kg / m2.
Who cannot join
- Absolute contraindications for performing physical exercise: recent AMI or unstable angina, uncontrolled hypertension, acute HF and complete AV block.
- Patients with osteoarticular pathology that limits their physical activity.
- Previous neurological pathology (Stroke, Enf. Of Parkinson's).
- Acute or chronic diseases decompensated or with lymphedema that makes difficult the accomplishment of the bioimpedanciometry.
- Patients using orthopedic devices and prostheses or pacemakers that interfere with gait or impede the achievement of bioimpedanciometry.
- BMI less than 23 and / or an involuntary weight loss of 3kg or more in the last 3 months.
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- Psychiatric disorders that hinder adherence to treatment.
- Moderate to severe Chronic Renal Disease
- Patient who does not agree to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical exercise at home or supervised.
Read the detailed description
The supplemental intake of L-carnitine improves the physical functioning of the pre-fragile and fragile elder of the community.
Circulating L-carnitine levels increase after administration of the supplement. The impact on the function of L-carnitine in combination with physical exercise will be studied in a population of older adults in Montevideo.
The sample will be divided into 3 groups, according to the intervention:
Group 1: Patients who will receive L-Carnitine in addition to a manual to perform physical exercise at home.
Group 2: Patients receiving L-Carnitine plus supervised exercise plan. Group 3: Patients receiving placebo and supervised exercise plan. All three groups will be evaluated for functional and anthropometric parameters: prior, during and after intervention. In addition, the dosage of L-carnitine and acetylcarnitine will be evaluated before and after the intervention.
- Conditions
- Carnitine; Muscle, Functional Status, Old Age; Debility
- Being tested
- L Carnitine, Supervised exercise, Placebos, Exercise at home
- Keywords
- carnitine, elderly, functional status
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L CarnitineDrug
L Carnitine liquid, single daily dose of 2g orally.
Supervised exerciseBehavioural
Modified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear.
PlacebosDrug
Liquid substance, similar to the one containing L carnitine, in the same presentation
Exercise at homeBehavioural
A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision
| Study group | Role | What they receive |
|---|---|---|
| L Carnitine + Exercise at home | Active comparator | Patients who will receive L Carnitine, in liquid form, at a dosage of 2g per day, in a single intake, in addition to physical exercise advice at home for which a manual will be delivered in the consultation, for 12 weeks. Receives: Drug: L Carnitine; Behavioral: Exercise at home |
| L Carnitine + supervised exercise | Experimental | Patients receiving L Carnitine, in liquid form, at doses of 2g per day, in a single intake, in addition to a supervised physical exercise plan, for 12 weeks. Receives: Drug: L Carnitine; Behavioral: Supervised exercise |
| Placebos + supervised exercise | Placebo comparator | Patients receiving placebo and supervised exercise plan. Receives: Behavioral: Supervised exercise; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in elderly's function
Independence Scales for Activities of Daily Living
Measured: 12 weeks
Gait speed
Gait speed measured after the intervention
Measured: 12 weeks
Elderly's physical performance
Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).
Measured: 12 weeks
Secondary outcomes (1)
Changes in the expression of fragility criteria
The Fragility criteria will be measured according to criteria promulgated and validated by Fried. The 5 original criteria will be used, but some measures to characterize the fragility will be adapted to the modifications of Avila-Funes.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Jan 2017
- Primary completion31 Aug 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carnitine; MuscleStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clínicas Dr. Manuel Quintela
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Republic, Uruguay
- Responsible party
- Principal investigator, Ana Barboza, Hospital de Clínicas Dr. Manuel Quintela
- Investigators
- Aldo Sgaravatti, MD, Study director, HospítalCDMQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180424
- Sponsor's protocol ID
- Protocolo L-Carnitina
- Status last verified
- Jun 2017
- First submitted
- 31 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Functional Status in Older Adults Treated With L-Carnitine
- ClinicalTrials.gov ID
- NCT03180424
- Acronym / sponsor ID
- Protocolo L-Carnitina
- Conditions
- Carnitine; Muscle, Functional Status, Old Age; Debility
- Keywords
- carnitine, elderly, functional status
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clínicas Dr. Manuel QuintelaUniversity, hospital or other
- Collaborators
- University of the Republic, Uruguay
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 8 Jun 2017 (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.
This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical exercise at home or supervised.
Detailed description
The supplemental intake of L-carnitine improves the physical functioning of the pre-fragile and fragile elder of the community.
Circulating L-carnitine levels increase after administration of the supplement. The impact on the function of L-carnitine in combination with physical exercise will be studied in a population of older adults in Montevideo.
The sample will be divided into 3 groups, according to the intervention:
Group 1: Patients who will receive L-Carnitine in addition to a manual to perform physical exercise at home.
Group 2: Patients receiving L-Carnitine plus supervised exercise plan. Group 3: Patients receiving placebo and supervised exercise plan. All three groups will be evaluated for functional and anthropometric parameters: prior, during and after intervention. In addition, the dosage of L-carnitine and acetylcarnitine will be evaluated before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L Carnitine + Exercise at home | Active comparator | Drug: L Carnitine, Behavioral: Exercise at homePatients who will receive L Carnitine, in liquid form, at a dosage of 2g per day, in a single intake, in addition to physical exercise advice at home for which a manual will be delivered in the consultation, for 12 weeks. |
| L Carnitine + supervised exercise | Experimental | Drug: L Carnitine, Behavioral: Supervised exercisePatients receiving L Carnitine, in liquid form, at doses of 2g per day, in a single intake, in addition to a supervised physical exercise plan, for 12 weeks. |
| Placebos + supervised exercise | Placebo comparator | Behavioral: Supervised exercise, Drug: PlacebosPatients receiving placebo and supervised exercise plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patients who meet at least 2 criteria for the fragility phenotype of Linda Fried
- Ability to comply with aerobic physical activity of moderate intensity and basic resistance.
- Not depressed patients (Yesavage <5 in patients without previous depression or Hamilton <7 in patients in treatment for depression)
- MMSE (Mini-Mental State Examination) greater than 24 points.
- Independent or mildly dependent patients, Barthel> 95 points.
Key exclusion criteria (9 listed)
- Absolute contraindications for performing physical exercise: recent AMI or unstable angina, uncontrolled hypertension, acute HF and complete AV block.
- Patients with osteoarticular pathology that limits their physical activity.
- Previous neurological pathology (Stroke, Enf. Of Parkinson's).
- Acute or chronic diseases decompensated or with lymphedema that makes difficult the accomplishment of the bioimpedanciometry.
- Patients using orthopedic devices and prostheses or pacemakers that interfere with gait or impede the achievement of bioimpedanciometry.
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 |
|---|---|---|
| L CarnitineL Carnitine liquid, single daily dose of 2g orally. | Drug | L Carnitine + Exercise at home, L Carnitine + supervised exercise |
| Supervised exerciseModified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear. | Behavioural | L Carnitine + supervised exercise, Placebos + supervised exercise |
| PlacebosLiquid substance, similar to the one containing L carnitine, in the same presentation | Drug | Placebos + supervised exercise |
| Exercise at homeA schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision | Behavioural | L Carnitine + Exercise at home |
Primary outcome
Changes in elderly's function
Time frame: 12 weeks
Independence Scales for Activities of Daily Living
Gait speed
Time frame: 12 weeks
Gait speed measured after the intervention
Elderly's physical performance
Time frame: 12 weeks
Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).
1 secondary outcome
Changes in the expression of fragility criteria
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Aldo Sgaravatti, MD study director
HospítalCDMQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing L Carnitine, Supervised exercise and Exercise at home in people with Carnitine; Muscle and Functional Status, run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Jun 2017. 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 Uruguay. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Changes in elderly's function (time frame: 12 weeks). 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?
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 8 Jun 2017.