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Completed

NCT Number: NCT06943339

Impact of Enteral Nutrition Variants on Malnutrition and Biochemical Markers

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mehmet Akif Inan Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Serum Glucose Level (mg/dL)

    Time frame: Baseline and after 15 days

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

  2. Change in Serum Albumin Level (g/dL)

    Time frame: Baseline and after 15 days

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

  3. Change in Serum CRP Level (mg/L)

    Time frame: Baseline and after 15 days

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

  4. Change in Hemoglobin Level (g/dL)

    Time frame: Baseline and after 15 days

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

  5. Change in Serum Urea Level (mg/dL)

    Time frame: Baseline and after 15 days

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

  6. Change in Serum Creatinine Level (mg/dL)

    Time frame: Baseline and after 15 days

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

  7. Change in Lymphocyte Count (10^3/µL)

    Time frame: Baseline and after 15 days

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

  8. Change in Leukocyte Count (10^3/µL)

    Time frame: Baseline and after 15 days

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

  9. Change in Monocyte Count (10^3/µL)

    Time frame: Baseline and after 15 days

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

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

    Time frame: Baseline and after 15 days

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

  11. Change in Eosinophil Count (10^3/µL)

    Time frame: Baseline and after 15 days

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

  12. Change in Basophil Count (10^3/µL)

    Time frame: Baseline and after 15 days

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

Secondary outcomes

  1. Change in NRS-2002 Nutritional Risk Score

    Time frame: Baseline and after 15 days

    Change in NRS-2002 score, which evaluates the nutritional risk based on BMI, weight loss, food intake, and disease severity. Scores ≥3 indicate nutritional risk.

    Time Frame: Baseline and after 15 days Unit of Measure: Units on a scale (0-7)

  2. Change in Prognostic Nutrition Index (PNI)

    Time frame: Baseline and after 15 days

    Change in PNI score calculated as:

    PNI=(10×SerumAlbumin[g/dL])+(0.005×TotalLymphocyteCount[/mm3])PNI = (10 × Serum Albumin [g/dL]) + (0.005 × Total Lymphocyte Count [/mm³])PNI=(10×SerumAlbumin[g/dL])+(0.005×TotalLymphocyteCount[/mm3]) Scores <45 indicate malnutrition and immunosuppression risk.

  3. Change in Modified Glasgow Prognostic Score (mGPS)

    Time frame: Baseline and after 15 days

    Change in mGPS, based on CRP and albumin levels.

    Score 0: CRP ≤10 mg/L

    Score 1: CRP >10 mg/L and Albumin ≥3.5 g/dL

    Score 2: CRP >10 mg/L and Albumin <3.5 g/dL Time Frame: Baseline and after 15 days Unit of Measure: Categorical (0, 1, or 2)

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Collaborators

  • Sanliurfa Mehmet Akif Inan Education and Research Hospital

Registry information

Official study title

Effects of Different Compositions of Enteral Nutrition Products on Malnutrition and Biochemical Parameters

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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