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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02584907
Enrollment
88
Registered
2015-10-23
Start date
2015-10-31
Completion date
2017-04-01
Last updated
2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Keywords

Critically ill, Diet, Blood glucose

Brief 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

Interventions

OTHERHigh Fat Enteral Nutrition

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

Sponsors

Shahid Beheshti University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Blood Glucose1 year

Secondary

MeasureTime frame
Length of Stay in ICU1 year
Occurrence of Infection1 year

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026