Clinical Trials Directory

Trials / Completed

CompletedNCT02584907

Fat Based Enteral Nutrition for Blood Glucose Control in ICU

Effect of Fat Based Versus Glucose Based Enteral Nutrition on Serum Glucose Levels and Clinical Outcome in Hyperglycemic Patients in ICU

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
88 (actual)
Sponsor
Shahid Beheshti University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

In this randomized, double-blind clinical trial, eligible hospitalized ICU patients with EN will be included. Patients will be divided into two groups. The control group with the standard EN and intervention group with high fat EN. 50% of the total fat will be provided by olive oil. Nutritional intake record form will be completed and daily calorie intake will be calculated. High fat EN feeding will be offered for 15 consecutive days maximally. At the end of the study mean blood glucose, duration of hospitalization and rate of infection will be compared in two groups.

Detailed description

In this randomized, double-blind clinical trial, 88 eligible hospitalized ICU patients with EN will be included. Written consent form will be completed. Physical examination will be done by specialist and nutritional care process will be offered by an RD. Demographic, laboratory and nutritional data will be extracted and entered in prepared form. Venous blood samples will be taken and laboratory values will be measured and recorded at specified times. Patients will be divided into two groups. The control group with the standard EN (Protein; 20% carbohydrate; 50% and fat; 30% from total calories) and intervention group with high fat EN (Protein; 20% carbohydrate; 35% and fat; 45% from total calories). 50% of the total fat will be provided by olive oil. Any feeding rout such as naso - gastric , Percutaneous endoscopic gastrostomy (PEG ) or Percutaneous endoscopic jejunostomy (PEJ) with Intermittent feeding protocol will be accepted feeding method . Nutritional intake record form will be completed and daily calorie intake will be calculated. High fat EN feeding will be offered for 15 consecutive days maximally

Conditions

Interventions

TypeNameDescription
OTHERHigh Fat Enteral NutritionDiet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate

Timeline

Start date
2015-10-01
Primary completion
2017-04-01
Completion
2017-04-01
First posted
2015-10-23
Last updated
2017-04-17

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT02584907. Inclusion in this directory is not an endorsement.