Assessment of Nutrient Absorption in Enterally Fed Post-intensive Care Unit Patients Using Bomb Calorimetry: do the Calories Stick
STICKY
1 other identifier
interventional
20
1 country
2
Brief Summary
This study focuses on understanding how well patients who have recovered from an ICU stay absorb nutrients when receiving enteral (tube) feeding. Proper nutrition is crucial for recovery, but we don't fully understand how efficiently enteral feeding works in ICU survivors. The study will use advanced techniques like bomb calorimetry to measure the energy content of stool, and indirect calorimetry to measure patients' resting energy expenditure (REE). This will help assess the effectiveness of enteral feeding in these patients, providing valuable information about their metabolic needs and nutritional status. The study will also look into the environmental impact of enteral feeding, particularly food waste. By understanding how much of the nutrition is absorbed versus excreted, the study hopes to suggest more sustainable feeding practices and reduce unnecessary waste in hospitals. Key Goals:
- Primary Goal: Measure how much energy from enteral feeding is absorbed by patients post-ICU by analyzing their stool and energy expenditure.
- Secondary Goal: Assess how enteral feeding can be made more sustainable, with less waste generated from unused nutritional products. This research will help improve nutritional care for ICU patients, enhance recovery, and potentially lead to more environmentally friendly healthcare practices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedStudy Start
First participant enrolled
January 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 1, 2026
April 1, 2026
2.2 years
March 28, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
caloric absorption efficiency
the caloric intake from enteral feeding will be compared with the caloric content of the excreted stool. The difference between these two values will provide an estimate of how efficiently the body absorbs the administered nutrients.
From screening to study completion for the patient, on average 3 days
Resting Energy Expenditure (REE)
The study will measure the resting energy expenditure of post-ICU patients using indirect calorimetry, which provides a real-time measure of the patients' basal metabolic rate and energy needs.
From screening to study completion for the patient, on average 3 days
Secondary Outcomes (3)
Nutrient Absorption Efficiency
From screening to study completion for the patient, on average 3 days
Waste Generation from Enteral Feeding Solutions and Tubing
From screening to study completion for the patient, on average 3 days
Overall Food Waste in Hospitals
From screening to study completion for the patient, on average 3 days
Study Arms (1)
Participants
EXPERIMENTAL20 post-ICU patients who are fully enterally fed (PEG- or nasogastric tube). Step-by-Step Process: Every time a patient is included, all steps (caloric intake measurement, stool sample collection, blending, freezing, and freeze drying) will be performed sequentially. Bomb Calorimetry can be conducted either systematicallyfor a few patients at a time or all at once after all samples have been collected.
Interventions
* a nonabsorbable blue dye marker will be administered at the start and end of the stool collection period to precisely indentify the stool produced within a specific time frame. * stool will be collected for three days. Each sample will be collected, weighted and labeled with the date and time, then stored at -20°C. * only stool samples from the appearance of the first dye marker to the appearance of the second dye marker will be saved and analyzed. * bomb calorimetry preparation * blending and dilution: each stool sample will be put into a blender and mixed with an equal amount of water * freeze dying: the diluted stool will be placed into freeze-dye flasks and frozen at -20°C. The next day, the flasks will be placed into a freeze dryer for 48hours. * pellet formation: the freeze-dried samples will be formed into 1-gram pellets and stored until calorimetry * calorimetry analysis: the Parr 6200 isoperibol calorimeter will be used to measure the energy content of the stool pellets
performing indirect calorimetry to measure the REE of each patient
Detailed daily tracking of the enteral feeding provided to each patient, inclusing the type and amount of nutritional formula administered. Apart from the enteral intake, supplemental calories provided by infusion (e.g. glucose) will be recorded to ensure accurate measurement of caloric intake.
Eligibility Criteria
You may qualify if:
- age of 18 years or older
- minimum ICU stay of 7 days
- fully dependent on enteral feeding (nasogastric or PEG-tube)
- ability of the patient or representative to understand and sign written informed consent in Dutch, French or English
You may not qualify if:
- known inflammatory bowel disease
- known malabsorptive gastrointestinal disease
- history of small bowel resection
- concomitant use of serotoninergic or sympathomimetic medications (oa. setrone, tryptans, antidepressants, methylphenidate, monoamine oxidase inhibitors, tramadol)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitair Ziekenhuis Brussellead
- Société des Produits Nestlé (SPN)collaborator
Study Sites (2)
UZ Brussel
Brussels, Belgium
UZ Brussel
Jette, 1090, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 11, 2025
Study Start
January 8, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04