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

U

University of Cadiz

Status and phase

Completed
Phase 4

Conditions

Malnutrition
Multimorbidity
Pressure Ulcer Prevention
Comorbidity

Treatments

Dietary Supplement: Atémpero
Dietary Supplement: Control (Standard treatment)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

69 participants in 2 patient groups

Intervention Group (Atémpero)
Experimental group
Description:
Participants received an arginine-enriched ONS called Atémpero®.
Treatment:
Dietary Supplement: Atémpero
Control Group
Active Comparator group
Description:
Participants received a complete high-protein, high-calorie diet with mixed fiber.
Treatment:
Dietary Supplement: Control (Standard treatment)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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