Clinical trial NCT06943339: Impact of Enteral Nutrition Variants on Malnutrition and Biochemical Markers
Official title: Effects of Different Compositions of Enteral Nutrition Products on Malnutrition and Biochemical Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: malnutrition
intensive care
enteral nutrition
biochemical markers
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Sanliurfa Mehmet Akif Inan Education and Research Hospital
First posted: 2025-04-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Malnutrition is a common health problem, especially in individuals with chronic diseases, significantly decreases the quality of life and increases morbidity and mortality rates. Nutritional support plays a vital role in the prevention and treatment of malnutrition. Enteral nutrition, which is preferred especially in cases where oral nutrition is inadequate, is a frequently used method to ensure that patients receive sufficient amounts of energy and essential nutrients. The formulations of enteral nutrition products may vary according to the specific needs of the patient and the components of these products have a critical role in correcting malnutrition and improving biochemical parameters. However, studies on the efficacy of enteral products with different ingredients and their relationship with biochemical parameters in individuals at risk of malnutrition are very limited. This study aims to investigate the effects of enteral nutrition products with various compositions on malnutrition and biochemical parameters in intensive care unit patients.

This study is an observational and quasi-experimental study conducted in the Intensive Care Unit of Mehmet Akif Inan Training and Research Hospital. Inclusion criteria included being 18 years of age or older, receiving enteral nutrition during the study period (15 days) and having complete patient records. Exclusion criteria were receiving parenteral nutrition before starting enteral nutrition, patients with gastrointestinal problems contraindicating enteral nutrition, and patients who died within 15 days after starting enteral nutrition or whose formula changed. Within the scope of the research, it was planned to reach a total of 50 participants, 25 in each group. At the end of the research, 43 participants who received standard products (1kkal/1ml) and 30 participants who received products containing high energy and protein (1.5 kkal/1ml + protein content increased) were reached.

Patients included in the study design will be divided into two groups. One group will include the data of the participants receiving the standard product (1kkal/1ml) and the other group will include the data of the participants receiving the product containing high energy and protein (1.5 kkal/1ml + protein content increased). No intervention will be made by the researchers during the treatment process of the patients, only the nutritional status of the patients at the beginning of enteral nutrition and 15 days later (NRS-2002 (Nutritional Risk Score-2002), Prognostic nutrition index (PNI) and modified Glasgow prognostic score (mGPS)) and biochemical parameters will be evaluated.

NRS-2002: This scale is designed to assess risk factors associated with the patient's nutritional status and disease severity. The NRS-2002 is administered on admission and has the feature of adding an additional risk score for individuals over 70 years of age. The scale calculates a nutritional risk score based on objective criteria including the patient's body mass index, changes in dietary intake and severity of disease. The presence of malnutrition is defined when the scale score is 3 and above.

Prognostic nutrition index (PNI): This index, calculated with serum albumin level and total lymphocyte count factors, is scored by combining nutritional and immunological parameters. While albumin is an indicator of protein adequacy and nutritional status in the body, lymphocyte count reflects the immunological status of the body. A total score below 45 points is considered at risk for malnutrition and immunosuppression.

modified Glasgow prognostic score (mGPS)): This index, calculated on the basis of C-reactive protein (CRP) and albumin levels, represents a survival prognosis.

Biochemical results: Biochemical parameters such as glucose, albumin, CRP, haemoglobin, urea, creatinine, lymphocytes, leukocytes, monocytes, neutrophils, eosinophils, basophils will be recorded from patient files.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Serum Glucose Level (mg/dL)
timeFrame: Baseline and after 15 days
measure: Change in Serum Albumin Level (g/dL)
timeFrame: Baseline and after 15 days
measure: Change in Serum CRP Level (mg/L)
timeFrame: Baseline and after 15 days
measure: Change in Hemoglobin Level (g/dL)
timeFrame: Baseline and after 15 days
measure: Change in Serum Urea Level (mg/dL)
timeFrame: Baseline and after 15 days
measure: Change in Serum Creatinine Level (mg/dL)
timeFrame: Baseline and after 15 days
measure: Change in Lymphocyte Count (10^3/µL)
timeFrame: Baseline and after 15 days
measure: Change in Leukocyte Count (10^3/µL)
timeFrame: Baseline and after 15 days
measure: Change in Monocyte Count (10^3/µL)
timeFrame: Baseline and after 15 days
measure: Change in Neutrophil Count (10^3/µL)
timeFrame: Baseline and after 15 days
measure: Change in Eosinophil Count (10^3/µL)
timeFrame: Baseline and after 15 days
measure: Change in Basophil Count (10^3/µL)
timeFrame: Baseline and after 15 days
Secondary outcomes:
measure: Change in NRS-2002 Nutritional Risk Score
timeFrame: Baseline and after 15 days
measure: Change in Prognostic Nutrition Index (PNI)
timeFrame: Baseline and after 15 days
measure: Change in Modified Glasgow Prognostic Score (mGPS)
timeFrame: Baseline and after 15 days
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Mehmet Akif Inan Training and Research Hospital
Study officials:
References: