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Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase

NCT ID: NCT04459091

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2018-09-15

Brief Summary

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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

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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.

Conditions

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Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Amino essential acids

oral supplementation with a mixture of amino essential acids 8 gr die in two administrations for six weeks

Group Type EXPERIMENTAL

Amino Essential Acid

Intervention Type DIETARY_SUPPLEMENT

8 gr die in two administration

Placebo

placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

8 gr die in two administration

Interventions

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Amino Essential Acid

8 gr die in two administration

Intervention Type DIETARY_SUPPLEMENT

placebo

8 gr die in two administration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero Funzionale di Montescano

Montescano, Pavia, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 12390513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27856112 (View on PubMed)

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.

Reference Type RESULT
PMID: 31412042 (View on PubMed)

Other Identifiers

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2112

Identifier Type: -

Identifier Source: org_study_id