MalnutritionNCT06943339
Impact of Enteral Nutrition Variants on Malnutrition and Biochemical Markers
An observational study of Malnutrition, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Standard enteral nutrition and High energy and protein enteral nutrition
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Apr 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Being 18 years of age or older
- Receiving enteral nutrition during the study period (15 days)
- Having complete patient records
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mehmet Akif Inan Training and Research Hospital
Sanliurfa
About this study
Official title: Effects of Different Compositions of Enteral Nutrition Products on Malnutrition and Biochemical Parameters
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Standard enteral nutrition, High energy and protein enteral nutrition
- Keywords
- malnutrition, intensive care, enteral nutrition, biochemical markers
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard enteral nutritionOther
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 nutritionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard enteral nutrition group | Participants included in the group were those who consumed a standard enteral product (1kcal/1ml) for 15 days Receives: 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. Receives: Other: High energy and protein enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Glucose Level (mg/dL)
Change in fasting blood glucose levels (mg/dL) from baseline to Day 15.
Measured: Baseline and after 15 days
Change in Serum Albumin Level (g/dL)
Change in serum albumin concentration (g/dL) from baseline to Day 15.
Measured: 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.
Measured: Baseline and after 15 days
Change in Hemoglobin Level (g/dL)
Change in hemoglobin concentration (g/dL) from baseline to Day 15.
Measured: Baseline and after 15 days
Change in Serum Urea Level (mg/dL)
Change in serum urea levels (mg/dL) from baseline to Day 15.
Measured: Baseline and after 15 days
Change in Serum Creatinine Level (mg/dL)
Change in serum creatinine levels (mg/dL) from baseline to Day 15.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 15 days
Secondary outcomes (3)
Change in NRS-2002 Nutritional Risk Score
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)
Measured: Baseline and after 15 days
Change in Prognostic Nutrition Index (PNI)
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.
Measured: Baseline and after 15 days
Change in Modified Glasgow Prognostic Score (mGPS)
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)
Measured: Baseline and after 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Oct 2024
- Primary completion1 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Responsible party
- Principal investigator, HAKAN TOĞUÇ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943339
- Sponsor's protocol ID
- Inonu-NAD-HT-01
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from participants were gathered solely for research objectives, adhering strictly to the ethical principles of confidentiality and protection. As such, it is not available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Compositions of Enteral Nutrition Products on Malnutrition and Biochemical Parameters
- ClinicalTrials.gov ID
- NCT06943339
- Acronym / sponsor ID
- Inonu-NAD-HT-01
- Conditions
- Malnutrition
- Keywords
- malnutrition, intensive care, enteral nutrition, biochemical markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard enteral nutrition group | – | Other: Standard enteral nutritionParticipants included in the group were those who consumed a standard enteral product (1kcal/1ml) for 15 days |
| High energy and protein enteral nutrition group | – | Other: High energy and protein enteral nutritionParticipants included in the group were those who consumed high energy and protein enteral products (1.5 kcal/1ml + protein content increased) for 15 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Being 18 years of age or older
- Receiving enteral nutrition during the study period (15 days)
- Having complete patient records
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard enteral nutritionIt 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. | Other | Standard enteral nutrition group |
| High energy and protein enteral nutritionIt 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. | Other | High energy and protein enteral nutrition group |
Primary outcome
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.
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.
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.
Change in Hemoglobin Level (g/dL)
Time frame: Baseline and after 15 days
Change in hemoglobin concentration (g/dL) from baseline to Day 15.
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Change in NRS-2002 Nutritional Risk Score
Time frame: Baseline and after 15 days
Change in Prognostic Nutrition Index (PNI)
Time frame: Baseline and after 15 days
Change in Modified Glasgow Prognostic Score (mGPS)
Time frame: Baseline and after 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. The data from participants were gathered solely for research objectives, adhering strictly to the ethical principles of confidentiality and protection. As such, it is not available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Glucose Level (mg/dL) (time frame: Baseline and after 15 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.