Fat Based Enteral Nutrition for Blood Glucose Control in ICU

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hyperglycemia

Intervention / Treatment
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* Other: High Fat Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being on Enteral Nutrition BS≥ 200mg/dl Without Renal and Liver Failure Without Hyperlipidemia and Nephrotic Syndrome Without Infection Without Obesity Exclusion Criteria: Death or Discharge before Day 7

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Fat Enteral Nutrition<br>Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate | Other: High Fat Enteral Nutrition<br>* Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate<br>|
| No Intervention: Standered Enteral Nutrition<br>Diet in standard group will be 20% from protein, 30% from fat and 50% from carbohydrate | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in ICU |  | 1 year | 
| Occurrence of Infection |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critically ill, Diet, Blood glucose