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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06726486

Enrollment

Registered

2024-12-10

Start date

2022-01-01

Completion date

2023-04-30

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comorbidity, Malnutrition, Multimorbidity, Pressure Ulcer Prevention

Keywords

Multimorbidity, Comorbidity, Malnutrition, Pressure Ulcer, Supplements, Immunonutrients

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTAtémpero

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.

DIETARY_SUPPLEMENTControl (Standard treatment)

A complete high-protein and high-calorie diet with mixed fibre was administered.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Intervention model description

A single-blind parallel Randomized Controlled Clinical Trial.

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026