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Fat Based Enteral Nutrition for Blood Glucose Control in ICU

S

Shahid Beheshti University

Status

Completed

Conditions

Hyperglycemia

Treatments

Other: High Fat Enteral Nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT02584907
1395/34199

Details and patient eligibility

About

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.

Full 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

Enrollment

88 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

88 participants in 2 patient groups

High Fat Enteral Nutrition
Experimental group
Description:
Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate
Treatment:
Other: High Fat Enteral Nutrition
Standered Enteral Nutrition
No Intervention group
Description:
Diet in standard group will be 20% from protein, 30% from fat and 50% from carbohydrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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