Impact on Functional Status in Older Adults Treated With L-Carnitine

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.

Study Overview

• Status: Unknown
• Conditions: Functional Status; Old Age; Debility; Carnitine; Muscle
• Intervention / Treatment: Drug: L Carnitine; Behavioral: Exercise at home; Behavioral: Supervised exercise; Drug: Placebos

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Uruguay
  • Montevideo, Uruguay, 11600
    • Hospital de Clínicas Dr. Manuel Quintela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Psychiatric disorders that hinder adherence to treatment.
• Moderate to severe Chronic Renal Disease
• Patient who does not agree to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: L Carnitine + Exercise at home; 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.	Drug: L Carnitine; L Carnitine liquid, single daily dose of 2g orally.; Behavioral: Exercise at home; A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision
Experimental: L Carnitine + supervised exercise; 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.	Drug: L Carnitine; L Carnitine liquid, single daily dose of 2g orally.; Behavioral: Supervised exercise; 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.
Placebo Comparator: Placebos + supervised exercise; Patients receiving placebo and supervised exercise plan.	Behavioral: Supervised exercise; 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.; Drug: Placebos; Liquid substance, similar to the one containing L carnitine, in the same presentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in elderly's function	Independence Scales for Activities of Daily Living	12 weeks
Gait speed	Gait speed measured after the intervention	12 weeks
Elderly's physical performance	Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine blood levels of L carnitine and acetylcarnitine	Determine L-Carnitine and Acetylcarnitine levels in the study population before and after L carnitine supplementation.	12 weeks
Determine levels of ammonia in blood	Determine levels of ammonia in blood in the study population before and after L carnitine supplementation.	12 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clínicas Dr. Manuel Quintela
• Collaborators: University of the Republic, Uruguay
• Investigators: Study Director: Aldo Sgaravatti, MD, HospítalCDMQ

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): August 31, 2017
• Study Completion (Anticipated): September 30, 2017

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: elderly; functional status; carnitine
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: Protocolo L-Carnitina

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes