Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Amino essential acids oral supplementation with a mixture of amino essential acids 8 gr die in two administrations for six weeks |
Dietary Supplement: Amino Essential Acid
8 gr die in two administration
|
| Placebo Comparator: Placebo placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks |
Dietary Supplement: placebo
8 gr die in two administration
|
Outcome Measures
Primary Outcome Measures
- Serum Albumin Levels [eight weeks]
Number of patients who at discharge show levels of albuminemia> 0.35 gr / dl (normal level)
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
first episode of cerebral stroke
-
first taken in rehabilitation after hospitalization in the acute department
Exclusion Criteria:
-
neoplasia
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long-term corticosteroid therapy (> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero Funzionale di Montescano | Montescano | Pavia | Italy | 27040 |
Sponsors and Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- University of Pavia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Kimura Y, Yamada M, Kakehi T, Itagaki A, Tanaka N, Muroh Y. Combination of Low Body Mass Index and Low Serum Albumin Level Leads to Poor Functional Recovery in Stroke Patients. J Stroke Cerebrovasc Dis. 2017 Feb;26(2):448-453. doi: 10.1016/j.jstrokecerebrovasdis.2016.10.008. Epub 2016 Nov 14.
- Rodriguez de Turco EB, Belayev L, Liu Y, Busto R, Parkins N, Bazan NG, Ginsberg MD. Systemic fatty acid responses to transient focal cerebral ischemia: influence of neuroprotectant therapy with human albumin. J Neurochem. 2002 Nov;83(3):515-24.
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