Design and development of an anti-inflammatory formula for Oral Nutrition Support (ONS) and its effects on inflammatory markers, antioxidants status and clinical outcomes in critically ill patients admitted to the intensive care unit: A double blined randomized control trial

Design and development of an anti-inflammatory formula for Oral Nutrition Support (ONS) and its effects on inflammatory markers, antioxidants status and clinical outcomes in critically ill patients admitted to the intensive care unit

In this study, 74 critically ill adult patients, 24-48 hours after being admitted to the special care unit are selected based on the inclusion criteria and randomly assigned to two groups. After determining the daily needs of the intervention group and the control group, respectively, 500 cc of anti-inflammatory formula and 500 cc of standard formula will be received in 2 doses and in the form of a bolus, and the rest of the energy needed by the patients will be provided through hospital gavage.

This study is conducted on critically ill patients admitted to the intensive care unit of Imam Reza (AS) Mashhad Hospital. In this study, 74 critically ill patients were randomly assigned to one of two intervention or control groups and were subjected to intervention with anti-inflammatory formulation or standard formulation for 14 days. In this study, the patients and the statistical analyzer were blinded.

Inclusion criteria o Age 18-65 years o Digestive system with normal function o Has criteria for enteral nutrition Non-entry criteria o Patients who are hospitalized in the intensive care unit for less than 96 hours. o Patients who have a history of underlying diseases such as diabetes, congenital and immune disorders, kidney and liver failure, and pancreatitis. o Lack of consent of the patient or his legal guardian

Intervention group: 500 cc of anti-inflammatory oral nutrition formula Control group: 500 cc Standard Formula (Standard Entrameal )

Inflammatory factors hs-CRP and ESR TAC and MDA antioxidant factors SOFA disease severity measure

Block randomization will be with blocks of 4, the random list will be created by https://www.sealedenvelope.com/. Patients are assigned to two control and intervention groups using sealed envelopes with block randomization method. In this way, in blocks of 4 which are divided into four states and each of these states is randomly selected from the sealed envelopes, 4 people in the control and intervention groups are allocated based on the selected state of the sealed envelope. It will be given. The same process continues until the allocation of all participants in the control and intervention groups.

After the preparation of the sachet (containing the vitamins, minerals and nutrients mentioned) by the specialized pharmacy team and the professors of the pharmaceuticals department and then adding it to the standard Intramil formula to prepare the formula of the intervention group, both the control and intervention group formulas are transferred to the hospital and In the hospital kitchen, after preparing the gavage solution in bottles of the same shape, it is numbered and coded, and it is transferred to the ICU and given to the relevant nurse, and to the patients who were previously divided into two control and intervention groups. The approval will be divided according to the amount of calories required and the amount of volume requested by the patient's doctor. Considering that the researchers, nurses and patients do not know about the numbering and coding of the gavage solution of the patients, and due to the identical appearance, texture and organoleptic characteristics of the gavage solutions of the two groups, the blinding process is done with great care.

If necessary, the data will be unidentifiable and in accordance with the ethical standards existing at the deputy of research of the Faculty of Medical Sciences of Mashhad.

After finishing the study and defending of the student's dissertation, the findings of the study will be published as a thesis and valid articles.

All researchers in the field of health have the opportunity to use the findings of this study if they have written permission from the vice chancellor for research in Mashhad University of Medical Sciences.

After obtaining permission from the deputy of research of Mashhad University of Medical Sciences and the main executor of the project, further studies in this field will be available for the researchers.

Research Vice-President of Mashhad University of Medical Sciences, principal executor of the project (Dr. Reza Rezvani)

Obtaining written permission from the Research Vice-Chancellor of Mashhad University of Medical Sciences, then referring to the Faculty of Medicine of Mashhad University of Medical Sciences and obtaining permission from the main project manager (Dr. Reza Rezvani) and the second supervisor (Dr. Majid Ghayour-Mobarhan) and the director of the Department of Nutrition