Critical IllnessNCT06825377
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
A study testing Whey protein in people with Critical Illness and Malnutrition, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
The goal of this clinical trial is to determine the optimal protein administration strategy for enhancing both nutritional and clinical outcomes, as well as reducing complications and mortality in ICU patients at risk for refeeding syndrome (RS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critical Illness, Malnutrition, Refeeding Syndrome
- What is being tested?
- Whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- 13 Feb 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to cooperate and complete the informed consent form by the patient or legal guardian;
- age ≤ 18 years and < 65 years;
- Non-pregnant and non-lactating;
- Serum creatinine ≥ 1.1 mg/dl for women and ≥ 1.2 mg/dl for men;
- No organ failure at the time of study enrollment;
- Intervention initiation within 48 hours of ICU admission;
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- No history of metastatic cancer or end-stage disease;
- No absolute contraindications to enteral nutrition (e.g., persistent ileus, gastrointestinal ischemia, persistent or biliary vomiting, mechanical obstruction);
- No active infections, sepsis, severe sepsis, or septic shock;
- No intolerance to the whey protein supplement used in the current study;
- Not participating in other clinical trials concurrently with this study;
- No clinical conditions with higher or lower protein needs, such as burns, sepsis, cirrhosis, or chronic kidney disease;
- No diabetes with severe complications such as ketoacidosis, hyperosmolar coma, or acidosis.
Who cannot join
- Unwillingness to continue cooperation during study;
- Discharge or death of the patient earlier than 5 days from the start of the intervention;
- Occurrence of side effects during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences
Tehran
About this study
Official title: Comparing the Effects of High-protein Nutritional Support with Standard Protein Nutritional Support Through the Administration of Whey Protein Supplements on Clinical Outcomes of Critically Ill Patients At Risk for Refeeding Syndrome: a Randomized Comparative Clinical Trial
The goal of this clinical trial is to determine the optimal protein administration strategy for enhancing both nutritional and clinical outcomes, as well as reducing complications and mortality in ICU patients at risk for refeeding syndrome (RS). This study will include critically ill patients at risk for RS who are receiving supportive nutrition. The primary hypothesis is that higher protein intake will lead to a decreased incidence of refeeding syndrome. It is also expected that patients receiving more protein will have better clinical outcomes, lower mortality, and shorter ICU and hospital stays.
Read the detailed description
Patients will be randomly assigned to two groups: the high-protein group and the standard-protein group. Upon ICU admission, and after meeting the inclusion criteria and identifying a risk of refeeding syndrome (RS), they will be allocated to one of the two groups. Patient selection for RS risk will be based on the diagnostic criteria outlined in the 2020 ASPEN guidelines. The m-NUTRIC and APACHE II scores will be calculated for all patients at ICU admission and 24 hours before the initiation of feeding. Monitoring for multi-organ dysfunction syndrome (MODS) will involve daily laboratory tests and organ failure assessment using the SOFA score.
Before starting the nutritional intervention, all patients will receive 100 mg of thiamine daily for one week, along with a daily multivitamin-mineral supplement. Due to the risk of RS, calorie intake will begin at low levels and will be cautiously increased in both groups. To calculate the energy needs, ideal body weight will be used. In the high-protein group, the target protein intake will be 2 grams per kilogram of body weight per day, while in the standard-protein group, it will be 1.3 grams per kilogram of body weight per day. Protein will be introduced gradually, starting from a low level, as part of nutritional support, with whey protein powder added if needed as a supplement. If serum creatinine levels rise, protein powder will be removed from the patient's diet. The intervention duration will be 14 days, with a minimum of 5 days.
The primary clinical outcome is the incidence of refeeding syndrome (RS), while secondary outcomes include the occurrence of infections, hospital length of stay, ICU length of stay, multi-organ failure, and mortality within 45 days of admission. RS will be diagnosed according to the 2020 ASPEN guidelines. Serum concentrations of potassium, magnesium, phosphate, glucose, urea, and creatinine will be measured daily for one week.
- Being tested
- Whey protein
- Keywords
- Refeeding syndrome, Critically ill, High-protein, Complication, Malnutrition, mortality
- Medical subject headings
- Critical Illness, Malnutrition, Refeeding Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Whey protein powder will be provided with nutritional support in both groups if needed to meet the target protein intake.
| Study group | Role | What they receive |
|---|---|---|
| High-protein | Experimental | The target protein intake of 2 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement. Receives: Dietary Supplement: Whey protein |
| Standard-protein | Active comparator | The target protein intake of 1.3 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement. Receives: Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with refeeding syndrome
Refeeding syndrome will be diagnosed based on a decrease in serum levels of electrolytes, including potassium, magnesium, and phosphate, within the first 5 days of nutrition delivery.
Measured: within the first 5-7 days of nutrition delivery
Secondary outcomes (5)
Incidence of infection
Determining and comparing the incidence of infection and its duration
Measured: Within 5-14 days of nutrition delivery
Number of participants with organ failure as measured by SOFA score
Organ failure will be assessed using the SOFA Score (Sequential Organ Failure Assessment), which evaluates the function of the following organ systems:
Cardiovascular Respiratory Renal Hepatic Coagulation Neurological
Measured: Within 5-14 days of nutrition delivery
Duration of ICU stay
Measured: up to 7 weeks after admission
Duration of hospital stay
Measured: up to 7 weeks after admission
Mortality
45-day mortality from the time of ICU admission
Measured: up to 45-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start13 Feb 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University of Medical Sciences
- Investigators
- Zahra Vahdat Shariatpanahi Professor, Principal investigator, School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825377
- Sponsor's protocol ID
- 450/1272
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of High-protein Nutritional Support with Standard Protein Nutritional Support Through the Administration of Whey Protein Supplements on Clinical Outcomes of Critically Ill Patients At Risk for Refeeding Syndrome: a Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06825377
- Acronym / sponsor ID
- 450/1272
- Keywords
- Refeeding syndrome, Critically ill, High-protein, Complication, Malnutrition, mortality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 13 Feb 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.
The goal of this clinical trial is to determine the optimal protein administration strategy for enhancing both nutritional and clinical outcomes, as well as reducing complications and mortality in ICU patients at risk for refeeding syndrome (RS). This study will include critically ill patients at risk for RS who are receiving supportive nutrition. The primary hypothesis is that higher protein intake will lead to a decreased incidence of refeeding syndrome. It is also expected that patients receiving more protein will have better clinical outcomes, lower mortality, and shorter ICU and hospital stays.
Detailed description
Patients will be randomly assigned to two groups: the high-protein group and the standard-protein group. Upon ICU admission, and after meeting the inclusion criteria and identifying a risk of refeeding syndrome (RS), they will be allocated to one of the two groups. Patient selection for RS risk will be based on the diagnostic criteria outlined in the 2020 ASPEN guidelines. The m-NUTRIC and APACHE II scores will be calculated for all patients at ICU admission and 24 hours before the initiation of feeding. Monitoring for multi-organ dysfunction syndrome (MODS) will involve daily laboratory tests and organ failure assessment using the SOFA score.
Before starting the nutritional intervention, all patients will receive 100 mg of thiamine daily for one week, along with a daily multivitamin-mineral supplement. Due to the risk of RS, calorie intake will begin at low levels and will be cautiously increased in both groups. To calculate the energy needs, ideal body weight will be used. In the high-protein group, the target protein intake will be 2 grams per kilogram of body weight per day, while in the standard-protein group, it will be 1.3 grams per kilogram of body weight per day. Protein will be introduced gradually, starting from a low level, as part of nutritional support, with whey protein powder added if needed as a supplement. If serum creatinine levels rise, protein powder will be removed from the patient's diet. The intervention duration will be 14 days, with a minimum of 5 days.
The primary clinical outcome is the incidence of refeeding syndrome (RS), while secondary outcomes include the occurrence of infections, hospital length of stay, ICU length of stay, multi-organ failure, and mortality within 45 days of admission. RS will be diagnosed according to the 2020 ASPEN guidelines. Serum concentrations of potassium, magnesium, phosphate, glucose, urea, and creatinine will be measured daily for one week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein | Experimental | Dietary Supplement: Whey proteinThe target protein intake of 2 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement. |
| Standard-protein | Active comparator | Dietary Supplement: Whey proteinThe target protein intake of 1.3 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willingness to cooperate and complete the informed consent form by the patient or legal guardian;
- age ≤ 18 years and < 65 years;
- Non-pregnant and non-lactating;
- Serum creatinine ≥ 1.1 mg/dl for women and ≥ 1.2 mg/dl for men;
- No organ failure at the time of study enrollment;
Key exclusion criteria (3 listed)
- Unwillingness to continue cooperation during study;
- Discharge or death of the patient earlier than 5 days from the start of the intervention;
- Occurrence of side effects during the study
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 |
|---|---|---|
| Whey proteinWhey protein powder will be provided with nutritional support in both groups if needed to meet the target protein intake. | Dietary supplement | High-protein, Standard-protein |
Primary outcome
Number of participants with refeeding syndrome
Time frame: within the first 5-7 days of nutrition delivery
Refeeding syndrome will be diagnosed based on a decrease in serum levels of electrolytes, including potassium, magnesium, and phosphate, within the first 5 days of nutrition delivery.
5 secondary outcomes
Incidence of infection
Time frame: Within 5-14 days of nutrition delivery
Number of participants with organ failure as measured by SOFA score
Time frame: Within 5-14 days of nutrition delivery
Duration of ICU stay
Time frame: up to 7 weeks after admission
Duration of hospital stay
Time frame: up to 7 weeks after admission
Mortality
Time frame: up to 45-day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Zahra Vahdat Shariatpanahi Professor principal investigator
School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein in people with Critical Illness and Malnutrition, run by Shahid Beheshti University at 1 site in Iran.
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 13 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: looking for participants now, as of the sponsor's last update on 14 Feb 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 Iran. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zahra Vahdat Shariatpanahi Professor (0098-021-22357484, nutritiondata@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with refeeding syndrome (time frame: within the first 5-7 days of nutrition delivery). 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 14 Feb 2025.