Effect of high-dose protein compared to conventional protein on intestinal permeability, disease severity, and mortality in critically ill patients admitted to the intensive care units.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241129063891N1

Enrollment

Registered

2024-12-11

Start date

2025-03-02

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

critically ill patients admitted to the intensive care units. Illness, unspecified

Interventions

Intervention 1: Intervention group: High-protein enteral nutrition (1.6 g/kg/day). Intervention 2: Control group: Enteral nutrition with conventional protein intake (1.2 g/kg/day).

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Ages 18 to 65 (both sexes) At least 24 hours have passed since admission to the intensive care unit. At least 1 day has passed since the patient received enteral feeding. The patient is stable in hemodynamics At least 60% of the protein intake is provided by enteral feeding. Willingness to cooperate and sign the informed consent.

Exclusion criteria

Exclusion criteria: Death or discharge before 4th day consuming Glutamine supplementation NPO more than 4 days Contraindication to EN Unwillingness to cooperate in the project

Design outcomes

Primary

Measure	Time frame
Zonulin levels and intestinal permeability are increased in critically ill patients. Timepoint: zonulin levels will be assessed before the start of the intervention and on days 5 and 10. Method of measurement: Zonulin (ng/mL) will be measured from serum samples using a human zonulin ELISA kit with a sandwich ELISA method.;Mortality. Timepoint: SOFA Questionnaire. Method of measurement: Every other day - Scores range from 0 to 24 - higher values ??indicate organ dysfunction and a poor prognosis.;Disease Severity. Timepoint: APACHE questionnaire. Method of measurement: first day of admission - score between 1 and 71 - score above 34 show 85% mortality.;Nutritional risk assessment. Timepoint: The first 24 hours after admission to the ICU. Method of measurement: mNUTRIC score - 0 to 9 points - scores =4 indicate nutritional risk and are considered high risk and scores <4 indicate low nutritional risk.	—

Measure

Time frame

Zonulin levels and intestinal permeability are increased in critically ill patients. Timepoint: zonulin levels will be assessed before the start of the intervention and on days 5 and 10. Method of measurement: Zonulin (ng/mL) will be measured from serum samples using a human zonulin ELISA kit with a sandwich ELISA method.;Mortality. Timepoint: SOFA Questionnaire. Method of measurement: Every other day - Scores range from 0 to 24 - higher values ??indicate organ dysfunction and a poor prognosis.;Disease Severity. Timepoint: APACHE questionnaire. Method of measurement: first day of admission - score between 1 and 71 - score above 34 show 85% mortality.;Nutritional risk assessment. Timepoint: The first 24 hours after admission to the ICU. Method of measurement: mNUTRIC score - 0 to 9 points - scores =4 indicate nutritional risk and are considered high risk and scores <4 indicate low nutritional risk.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShonaz Ahmhmadikhatir

Mashhad University of Medical Sciences

Sh_khatir@yahoo.com+98 51 3800 2359

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026