NCT03180424

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospital de Clínicas Dr. Manuel Quintela · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.
DRUG	Placebos	Liquid substance, similar to the one containing L carnitine, in the same presentation
BEHAVIORAL	Exercise at home	A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-08-31
• Completion: 2017-09-30
• First posted: 2017-06-08
• Last updated: 2017-06-08

Locations

1 site across 1 country: Uruguay

Regulatory

• FDA-regulated drug study