Enteral Feeding Composition and Acute Respiratory Failure

Phase 2

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Other: high-protein low-carbohydrate diet with high olive oil; Other: high-protein low-carbohydrate diet with high sunflower oil

• Registration Number: NCT02421614
• Lead Sponsor: Zahra Vahdat Shariatpanahi

Brief Summary

This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-20
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• enrolled in ICU
• age older than 18 years old
• need to be mechanically ventilation
• have enteral feeding
• no previous diabetes
• no previous HIV infection
• no previous nervous system
• no previous liver failure
• no previous nephrotic syndrome
• not passed more than 48 hours from diagnose of acute respiratory failure

Exclusion Criteria

• death at less than three days of enteral feeding administration
• extubation at less than three days of enteral feeding administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high olive oli	high-protein low-carbohydrate diet with high olive oil	A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The percentage of olive oil will be half of total fat.
high sunflower oil	high-protein low-carbohydrate diet with high sunflower oil	A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The total fat will be sunflower oil.

Primary Outcome Measures

Name	Time	Method
length of ventilation	The number of days at least 3, to which days that patient extubated	The number of days from the patient intubation to his/her extubation

Secondary Outcome Measures

Name	Time	Method
Levels of Interleukin 6 (IL-6) in patient's vein blood	10 days
Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood	10 days
Levels of Total Antioxidant Capacity (TAC) in patient's vein blood	10 days
Levels of uric acid in patient's vein blood	10 days

Trial Locations

Locations (1)

Faculty of Nutrition Sciences and Food Technology; 🇮🇷 Tehran, Iran, Islamic Republic of