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
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 17, 2017
April 1, 2017
1.5 years
October 19, 2015
April 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Glucose
1 year
Secondary Outcomes (2)
Length of Stay in ICU
1 year
Occurrence of Infection
1 year
Study Arms (2)
High Fat Enteral Nutrition
EXPERIMENTALDiet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate
Standered Enteral Nutrition
NO INTERVENTIONDiet in standard group will be 20% from protein, 30% from fat and 50% from carbohydrate
Interventions
Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate
Eligibility Criteria
You may qualify if:
- Being on Enteral Nutrition
- BS≥ 200mg/dl
- Without Renal and Liver Failure
- Without Hyperlipidemia and Nephrotic Syndrome
- Without Infection
- Without Obesity
You may not qualify if:
- Death or Discharge before Day 7
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Nutrition Sciences and Food Technology
Tehran, Iran
Related Publications (1)
Wewalka M, Drolz A, Zauner C. Influence of fat-based versus glucose-based enteral nutrition formulas on glucose homeostasis. Crit Care. 2013; 17(Suppl 2): P250. Published online 2013 Mar 19. doi: 10.1186/cc12188. PMCID: PMC3642614.
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zahra Vahdat Shariatpanahi, MD, Ph.D
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 23, 2015
Study Start
October 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
April 17, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share