The aim of this study is to evaluate the preventive effects of high fat enteral feeding on glycemic control and clinical outcomes in critically ill patients. 48 normoglycemic patients, admitte to intensive care unit will randomly classified into three groups of 14 each. Control group (A) will receive carbohydrate-based diet (protein:20%, fat:30%, charbohydrate:50%), study groups will receive two types of high fat diet; group B (protein:20%, fat:45% including half of olive oil and half sunflower oil, charbohydrate:35%) and group C (protein:20%, fat:45% including sunflower oil, charbohydrate:35 %) in the first 48 h of admission. Plasma and capillary glucose levels, insulin requirements, Serum HLA-cholesterol level , organ failure and mortality will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111914901N9
Registration date:2016-11-27, 1395/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Zahra Vahdat Shariatpanahi
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
z.shariatpanahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2013-08-01, 1392/05/10
Expected recruitment end date
2015-12-10, 1394/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of macronutrient composition of the enteral diet on glycemic control in critically ill patients
Public title
The macronutrient composition of the diet and glycemic control in ICU
Purpose
Supportive
Inclusion/Exclusion criteria
Adult patients in both sexes who will be hospitalized in ICU and initiating enteral nutrition within 48 hours following the hospital admission, will be included in this study. Patients enrolled in other studies that are pregnant or with previous diabetes, hyperglycemia on admission, Body Mass Index (BMI) ≥ 30 kg/m2, hyperlipidemia, liver failure, nephrotic syndrome and any contraindication to enteral nutrition, will be excluded. Patients who are discharge or die before the fifth day of enteral nutrition administration will be also excluded from the study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Sciencees,
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
054575
Health conditions studied
1
Description of health condition studied
critically ill patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The glycemic control
Timepoint
daily
Method of measurement
glucose oxidas
2
Description
Lipid profile
Timepoint
day 0 and 10
Method of measurement
ELIZA
Secondary outcomes
1
Description
organ failure
Timepoint
daily
Method of measurement
clinical and paraclinical
2
Description
length of ICU stay
Timepoint
daily
Method of measurement
observation
Intervention groups
1
Description
intervention 1:high protein carbohydrate based diet
Category
Other
2
Description
intervention 2:high protein fat based based diet with high olive oil
Category
Other
3
Description
intervention 3:high protein fat based based diet with high sunflower oil
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Akram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Majid Hajifaraji
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutrition
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Phone
+98 212122357483
Fax
Email
z.shariatpanahi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutrition
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City
Tehran
Postal code
Phone
+98 212122357483
Fax
Email
z.shariatpanahi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutrition
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Phone
00
Fax
Email
z.shariatpanahi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)