Design and validation of a fasting mimicking diet

ICU-FM: Implementation into the intensive care unit (ICU) of the beneficial effects of fasting (mimicking diets) (FM)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98404761

Enrollment

Registered

2017-05-17

Start date

2017-06-01

Completion date

Unknown

Last updated

2020-06-08

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

Conditions

Prolonged critical illness Signs and Symptoms Prolonged critical illness

Interventions

Participants are randomised by central computer in permuted blocks (size unknown to all involved) in a 1:1 ratio to either the 12/12 (or 24/24 if 12 hours would be not sufficient) caloric restriction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult ICU-patients 2. Unable to eat by mouth 3. Expected on day 7 to stay 3 more days in ICU

Exclusion criteria

Exclusion criteria: 1. Patients with severe jaundice 2. Bilirubin > 5mg/dL, pregnant 3. Lactating patients

Design outcomes

Primary

Measure	Time frame
1. Plasma bilirubin is measured by colorimetric assay in the Laboratory of Intensive Care Medicine at baseline and after the first and second intervention time window (12 hours or 24 hours according to the study phase) 2. Insulin requirements (total dose delivered over intervention time interval, this is the last 12 hours or 24 hours according to the study phase) are measured by reviewing the ICU-PDMS (Patient Data Management System [Metavision]) at baseline and after the first and the second intervention time window (this is after 12 hours and 24 hours in the first phase and eventually after 24 hours and 48 hours in the second phase of the study)	—

Measure

Time frame

1. Plasma bilirubin is measured by colorimetric assay in the Laboratory of Intensive Care Medicine at baseline and after the first and second intervention time window (12 hours or 24 hours according to the study phase) 2. Insulin requirements (total dose delivered over intervention time interval, this is the last 12 hours or 24 hours according to the study phase) are measured by reviewing the ICU-PDMS (Patient Data Management System [Metavision]) at baseline and after the first and the second intervention time window (this is after 12 hours and 24 hours in the first phase and eventually after 24 hours and 48 hours in the second phase of the study)

—

Secondary

Measure	Time frame
1. Mortality is measured using data from the National Registry via Hospital Clinical Work Station (KWS) at 90 days 2. New ICU-Morbidity occurring in the first week after randomization is assessed by reviewing the ICU-PDMS (Patient Data Management System [Metavision]) at baseline and 7 days	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026