Recruiting

High-protein versus standard-protein nutrition for critically ill patients

Plain-English translation of NCT06825377 on ClinicalTrials.gov ↗ · Source last updated February 2025 · Translation generated August 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study compares two different levels of protein nutrition for people admitted to the intensive care unit (ICU) who are at risk for a serious condition called refeeding syndrome. Some participants will receive a higher-protein diet (using whey protein supplements), while others receive a standard-protein diet. Researchers want to see which approach is safer and leads to better outcomes.

When critically ill patients start eating again after a period of malnutrition, their bodies can experience a dangerous imbalance of minerals and electrolytes called refeeding syndrome. This study aims to find out whether increasing protein intake in a careful, monitored way can help prevent this life-threatening complication and improve overall recovery.

Do you qualify?

You likely qualify if…

you are between 18 and 65 years old
you are willing to participate and sign an informed consent form (or have a legal guardian do so)
you are not pregnant or breastfeeding
you have been admitted to the ICU and screened to be at risk for refeeding syndrome
you can begin the study within 48 hours of your ICU admission
you can receive nutrition through your digestive tract (no severe bowel blockages or damage)

You likely don't qualify if…

you have active infections, sepsis, or septic shock at the time of enrollment
you have a known allergy or intolerance to whey protein
you have severe diabetes complications such as diabetic ketoacidosis or severe kidney disease
you are already enrolled in another clinical trial
you are expected to be discharged or are unlikely to survive more than 5 days from the start of treatment

What participation looks like

You will be randomly assigned to receive either higher-protein or standard-protein nutrition while in the ICU. Before your nutrition begins, you will receive vitamin B1 (thiamine) and a multivitamin supplement for one week. Your nutrition will start at low levels and increase gradually to reduce refeeding risk. For at least 5 days (and up to 14 days), researchers will monitor you daily with blood tests to check your mineral levels, kidney function, and overall health. Your care team will watch for any signs of complications and adjust your nutrition plan if needed.

AI-generated summary from trial data · Aug 27, 2026 · Not medical advice

Trial locations(1 site)

Iran

Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences, Tehran