NCT04459091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

June 22, 2020

Last Update Submit

October 20, 2021

Conditions

Stroke Rehabilitation

Keywords

Serum AlbuminEssential Amino AcidFunctional Recovery

Outcome Measures

Primary Outcomes (1)

  • Serum Albumin Levels

    Number of patients who at discharge show levels of albuminemia\> 0.35 gr / dl (normal level)

    eight weeks

Secondary Outcomes (1)

  • Functional Independence Measure

    eight weeks

Study Arms (2)

Amino essential acids

EXPERIMENTAL

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

Dietary Supplement: Amino Essential Acid

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

Amino Essential AcidDIETARY_SUPPLEMENT

8 gr die in two administration

Amino essential acids
placeboDIETARY_SUPPLEMENT

8 gr die in two administration

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first episode of cerebral stroke
  • first taken in rehabilitation after hospitalization in the acute department

You may not qualify if:

  • neoplasia
  • long-term corticosteroid therapy (\> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montescano, Pavia, 27040, Italy

Location

Related Publications (3)

  • 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.

    PMID: 12390513BACKGROUND

  • 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.

    PMID: 27856112BACKGROUND

  • 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.

    PMID: 31412042RESULT

MeSH Terms

Interventions

Amino Acids, Essential

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 7, 2020

Study Start

January 10, 2018

Primary Completion

August 31, 2018

Study Completion

September 15, 2018

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)