Fat Based Enteral Nutrition for Blood Glucose Control in ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-04-01

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.

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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

Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High Fat Enteral Nutrition

Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate

Group Type EXPERIMENTAL

High Fat Enteral Nutrition

Intervention Type OTHER

Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate

Standered Enteral Nutrition

Diet in standard group will be 20% from protein, 30% from fat and 50% from carbohydrate

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High Fat Enteral Nutrition

Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate

Intervention Type OTHER

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