- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459091
Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase
Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Patients With Cerebral Ictus in Rehabilitation Phase
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pavia
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Montescano, Pavia, Italy, 27040
- ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero Funzionale di Montescano
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- first episode of cerebral stroke
- first taken in rehabilitation after hospitalization in the acute department
Exclusion Criteria:
- neoplasia
- long-term corticosteroid therapy (> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
|
8 gr die in two administration
|
Placebo Comparator: Placebo
placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks
|
8 gr die in two administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Albumin Levels
Time Frame: eight weeks
|
Number of patients who at discharge show levels of albuminemia> 0.35 gr / dl (normal level)
|
eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Independence Measure
Time Frame: 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.
|
eight weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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. doi: 10.1046/j.1471-4159.2002.01121.x.
- 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.
- Aquilani R, Maestri R, Boselli M, Achilli MP, Arrigoni N, Bruni M, Dossena M, Verri M, Buonocore D, Pasini E, Barbieri A, Boschi F. The relationship between plasma amino acids and circulating albumin and haemoglobin in postabsorptive stroke patients. PLoS One. 2019 Aug 14;14(8):e0219756. doi: 10.1371/journal.pone.0219756. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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