Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase
- Conditions
- Stroke Rehabilitation
- Interventions
- Dietary Supplement: placeboDietary Supplement: Amino Essential Acid
- Registration Number
- NCT04459091
- Lead Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Brief Summary
In addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. The circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage.
In the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke.
- Detailed Description
In addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. In the patients admitted to the Montescano Neuromotor Rehabilitation Division, the prevalence of hypoalbuminemia is high at the time of admission and remains high, even if decreased, at discharge. The circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage. In the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke.
Several factors induce the use of free essential amino acids: they are the most efficient inducers of protein synthesis and albumin is a protein; free essential amino acids and not those contained in proteins allow a more reliable use of the isoleucine and tryptophan, true nutrients limiting the hepatic synthesis of albumin; the free essential amino acids have a faster and complete intestinal absorption of the essential amino acids derived from protein digestion.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- first episode of cerebral stroke
- first taken in rehabilitation after hospitalization in the acute department
- neoplasia
- long-term corticosteroid therapy (> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks Amino essential acids Amino Essential Acid oral supplementation with a mixture of amino essential acids 8 gr die in two administrations for six weeks
- Primary Outcome Measures
Name Time Method Serum Albumin Levels eight weeks Number of patients who at discharge show levels of albuminemia\> 0.35 gr / dl (normal level)
- Secondary Outcome Measures
Name Time Method Functional Independence Measure eight weeks The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability. Range total FIM score 18-126. High score corresponds to better outcome.
Trial Locations
- Locations (1)
ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero Funzionale di Montescano
🇮🇹Montescano, Pavia, Italy