Impact of Enteral Nutrition Variants on Malnutrition and Biochemical Markers

NCT06943339 | Completed

• 1 other identifier: Inonu-NAD-HT-01
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of consumption of enteral nutrition products with different compositions on malnutrition and biochemical parameters in intensive care unit patients.

Conditions

Malnutrition

Keywords

malnutrition; intensive care; enteral nutrition; biochemical markers

Outcome Measures

Primary Outcomes (12)

• Change in Serum Glucose Level (mg/dL)

  Change in fasting blood glucose levels (mg/dL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Serum Albumin Level (g/dL)

  Change in serum albumin concentration (g/dL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Serum CRP Level (mg/L)

  Change in C-reactive protein levels (mg/L) from baseline to Day 15.

  Baseline and after 15 days

• Change in Hemoglobin Level (g/dL)

  Change in hemoglobin concentration (g/dL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Serum Urea Level (mg/dL)

  Change in serum urea levels (mg/dL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Serum Creatinine Level (mg/dL)

  Change in serum creatinine levels (mg/dL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Lymphocyte Count (10^3/µL)

  Change in absolute lymphocyte count (10\^3/µL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Leukocyte Count (10^3/µL)

  Change in total leukocyte count (10\^3/µL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Monocyte Count (10^3/µL)

  Change in absolute monocyte count (10\^3/µL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Neutrophil Count (10^3/µL)

  Change in absolute neutrophil count (10\^3/µL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Eosinophil Count (10^3/µL)

  Change in absolute eosinophil count (10\^3/µL) from baseline to Day 15.

  Baseline and after 15 days

• Change in Basophil Count (10^3/µL)

  Change in absolute basophil count (10\^3/µL) from baseline to Day 15.

  Baseline and after 15 days

Secondary Outcomes (3)

• Change in NRS-2002 Nutritional Risk Score

  Baseline and after 15 days

• Change in Prognostic Nutrition Index (PNI)

  Baseline and after 15 days

• Change in Modified Glasgow Prognostic Score (mGPS)

  Baseline and after 15 days

Study Arms (2)

Standard enteral nutrition group

Participants included in the group were those who consumed a standard enteral product (1kcal/1ml) for 15 days

Other: Standard enteral nutrition

High energy and protein enteral nutrition group

Participants included in the group were those who consumed high energy and protein enteral products (1.5 kcal/1ml + protein content increased) for 15 days.

Other: High energy and protein enteral nutrition

Interventions

Standard enteral nutrition OTHER

It will include the baseline and 15-day follow-up data of the patients in the standard enteral nutrition group for standard product (1kkal/1ml) intake. No intervention will be made by the researchers during the treatment process of the patients.

Standard enteral nutrition group

High energy and protein enteral nutrition OTHER

It will include the baseline and 15-day follow-up data of the patients in the high energy and protein enteral nutrition group for the intake of high energy and protein containing product (1.5kkal/1ml + protein content increased). No intervention will be made by the researchers during the treatment process of the patients.

High energy and protein enteral nutrition group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years of age receiving enteral nutrition who were treated in the Intensive Care Unit of Mehmet Akif Inan Training and Research Hospital were included.

You may qualify if:

• Being 18 years of age or older
• Receiving enteral nutrition during the study period (15 days)
• Having complete patient records

You may not qualify if:

• Receiving parenteral nutrition before starting enteral nutrition
• Patients with gastrointestinal problems contraindicating enteral nutrition
• Patients who died within 15 days after starting enteral nutrition or whose formula changed

Sponsors & Collaborators

• Inonu University: lead
• Sanliurfa Mehmet Akif Inan Education and Research Hospital: collaborator

Study Sites (1)

Mehmet Akif Inan Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: April 24, 2025
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)