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Fat Based Enteral Nutrition for Blood Glucose Control in ICU

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
High Fat Enteral Nutrition
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring Critically ill, Diet, Blood glucose

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Nutrition Sciences and Food Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High Fat Enteral Nutrition

Standered Enteral Nutrition

Arm Description

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

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

Outcomes

Primary Outcome Measures

Blood Glucose

Secondary Outcome Measures

Length of Stay in ICU
Occurrence of Infection

Full Information

First Posted
October 19, 2015
Last Updated
April 13, 2017
Sponsor
Shahid Beheshti University
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1. Study Identification

Unique Protocol Identification Number
NCT02584907
Brief Title
Fat Based Enteral Nutrition for Blood Glucose Control in ICU
Official Title
Effect of Fat Based Versus Glucose Based Enteral Nutrition on Serum Glucose Levels and Clinical Outcome in Hyperglycemic Patients in ICU
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Critically ill, Diet, Blood glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Fat Enteral Nutrition
Arm Type
Experimental
Arm Description
Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate
Arm Title
Standered Enteral Nutrition
Arm Type
No Intervention
Arm Description
Diet in standard group will be 20% from protein, 30% from fat and 50% from carbohydrate
Intervention Type
Other
Intervention Name(s)
High Fat Enteral Nutrition
Intervention Description
Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate
Primary Outcome Measure Information:
Title
Blood Glucose
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Length of Stay in ICU
Time Frame
1 year
Title
Occurrence of Infection
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Vahdat Shariatpanahi, MD, Ph.D
Organizational Affiliation
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nutrition Sciences and Food Technology
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Links:
URL
http://www.ccforum.com
Description
Critical Care

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Fat Based Enteral Nutrition for Blood Glucose Control in ICU

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