Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores

December 9, 2024 updated by: Antonio Jesús Marín Paz, University of Cadiz

Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores: a Randomized Controlled Trial

The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients.

Participants will take enteral formula (a complete hyperproteic and hypercaloric oral nutritional supplement with a fibre mixture enriched in omega 3, L-arginine and nucleotides, providing vitamin C and Zinc) or a hyperproteic and hypercaloric oral nutritional supplement with fibre mixture every day for 30 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cadiz
      • Algeciras, Cadiz, Spain, 11207
        • Punta Europa University of Cadiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized chronic patients with complex needs in the Internal Medicine Department of a regional hospital.
  • Malnourished or at risk of malnutrition.
  • Moderate-high risk of developing pressure-related injuries or the presence of pressure-related injuries.

Exclusion Criteria:

  • Limitations in oral intake (due to pathologies, state of health, among others).
  • Contraindications for using the oral route and digestive intolerance or allergy to any of the components of the products.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (Atémpero)
Participants received an arginine-enriched ONS called Atémpero®.
Dietary supplement: Atémpero
A complete hyperproteic and hypercaloric diet with a mixture of fibres enriched in omega 3, L-arginine and nucleotides (which provides vitamin C and Zinc) was administered.
Active Comparator: Control Group
Participants received a complete high-protein, high-calorie diet with mixed fiber.
Dietary supplement: Control (Standard treatment)
A complete high-protein and high-calorie diet with mixed fibre was administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of pressure-related injuries
Time Frame: 15 and 30 days
Dichotomous variable: Yes/No.
15 and 30 days
Risk of developing pressure-related injuries
Time Frame: 15 and 30 days
Measurement instrument: Braden scale (low risk, moderate risk, high risk).
15 and 30 days
Categorization of pressure-related injuries
Time Frame: 15 and 30 days
Measurement instrument: PUSH scale (I, II, III, IV).
15 and 30 days
Pressure-related injuries healing
Time Frame: 15 and 30 days
Measurement instrument: PUSH scale (closed, epithelial tissue, granulation tissue, sphacelium, necrotic tissue).
15 and 30 days
Degree of dependence
Time Frame: 0, 15, and 30 days.
Measurement instruments (description): Barthel score (independent, mild, moderate, severe).
0, 15, and 30 days.
Weight loss
Time Frame: 0, 15 and 30 days.
Measurement instruments (description): Weight scale (kg).
0, 15 and 30 days.
% of dietary intake
Time Frame: 15 and 30 days.
0%, 25%, 50%, 75%, 100% intake.
15 and 30 days.
ONS adherence
Time Frame: 15 and 30 days.
0%, 25%, 50%, 75%, 100% intake.
15 and 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Collaborators

Instituto de investigación e innovación biomédica de Cádiz
Vegenat Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available after publication of the study results.

IPD Sharing Time Frame

Unending.

IPD Sharing Access Criteria

All data from this study will be available upon request to the author by correspondence, under justified reasons.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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