Enteral Feeding Composition and Acute Respiratory Failure

NCT02421614 | Completed Phase 2

• 1 other identifier: 054575
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

acute respiratory failure; lung; enteral feeding; feeding composition; olive; high fat

Outcome Measures

Primary Outcomes (1)

• length of ventilation

  The number of days from the patient intubation to his/her extubation

  The number of days at least 3, to which days that patient extubated

Secondary Outcomes (4)

• 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

• Levels of Interleukin 6 (IL-6) in patient's vein blood

  10 days

Study Arms (3)

high olive oli

EXPERIMENTAL

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.

Other: high-protein low-carbohydrate diet with high olive oil

high sunflower oil

EXPERIMENTAL

A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The total fat will be sunflower oil.

Other: high-protein low-carbohydrate diet with high sunflower oil

kitchen formula

NO INTERVENTION

A high protein kitchen diet for tube feeding will be administered to acute respiratory failure patients.

Interventions

high-protein low-carbohydrate diet with high olive oil OTHER

high olive oli

high-protein low-carbohydrate diet with high sunflower oil OTHER

high sunflower oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zahra Vahdat Shariatpanahi: lead

Study Sites (1)

Faculty of Nutrition Sciences and Food Technology

Tehran, Iran

Location

MeSH Terms

Interventions

Diet, High-Protein Low-Carbohydrate

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet, High-Protein; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 20, 2015
• Study Start: August 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2015-11

Locations

IR (1)