Clinical trial NCT06726486: Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multimorbidity
Comorbidity
Malnutrition
Pressure Ulcer Prevention
Keywords: Multimorbidity
Comorbidity
Malnutrition
Pressure Ulcer
Supplements
Immunonutrients
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Vegenat Healthcare
name: Instituto de investigación e innovación biomédica de Cádiz
First posted: 2024-12-10
Enrollment: 69
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind parallel Randomized Controlled Clinical Trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of pressure-related injuries
timeFrame: 15 and 30 days
measure: Risk of developing pressure-related injuries
timeFrame: 15 and 30 days
measure: Categorization of pressure-related injuries
timeFrame: 15 and 30 days
measure: Pressure-related injuries healing
timeFrame: 15 and 30 days
measure: Degree of dependence
timeFrame: 0, 15, and 30 days.
measure: Weight loss
timeFrame: 0, 15 and 30 days.
measure: % of dietary intake
timeFrame: 15 and 30 days.
measure: ONS adherence
timeFrame: 15 and 30 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Algeciras
country: Spain
facility: Punta Europa University of Cadiz
state: Cadiz
Study officials:
References:
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