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OpenTrials
Completed

NCT Number: NCT02584907

Fat Based Enteral Nutrition for Blood Glucose Control in ICU

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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Key information

Conditions

Hyperglycemia Critical Illness Disease Attributes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nutrition Sciences and Food Technology

Tehran, Iran

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Fat Enteral Nutrition

Other

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

Primary outcomes

  1. Blood Glucose

    Time frame: 1 year

Secondary outcomes

  1. Length of Stay in ICU

    Time frame: 1 year

  2. Occurrence of Infection

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2015
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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