Resting Energy Expenditure by Gastrointestinal Functional Status
Recruiting now · Not applicable
Conditions studied: Intestinal Failure, Short Bowel Syndrome
In brief
This prospective, comparative interventional study will evaluate resting energy expenditure in adults with different gastrointestinal functional status. A total of 92 participants aged 18 to 65 years will be included: 30 healthy adults with normal gastrointestinal function and 62 patients with clinically confirmed intestinal failure. The intestinal failure group will include patients with short bowel syndrome and patients with other causes of intestinal failure. Participants will be assigned to one of two protocol-defined groups according to their gastrointestinal functional status. Each participant will attend one study visit lasting approximately 90 to 120 minutes. The research procedures will include measurement of resting energy expenditure by indirect calorimetry after an overnight fast, assessment of body composition by dual-energy X-ray absorptiometry and bioelectrical impedance analysis, and blood sampling for inflammatory markers. The primary objective is to compare resting energy expenditure between healthy participants and patients with intestinal failure and to determine whether resting energy expenditure differs according to the underlying cause of intestinal failure. Secondary objectives are to evaluate the associations between resting energy expenditure, lean body mass, fat mass, phase angle, and inflammatory markers. The results may contribute to more individualized nutritional management of patients with intestinal failure.
Key facts
- Study ID
- NCT07714499
- Run by
- Institute of Oncology Ljubljana
- People needed
- 92
- Starts
- 2025-10-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Group A - Healthy Controls:
- Age 18 to 65 years
- No diagnosed chronic diseases
- No hospitalization within the previous 30 days
- No acute illness within the previous 14 days
- Group B - Participants With Intestinal Failure:
- Age 18 to 65 years
- Diagnostically confirmed intestinal failure
- Stable clinical condition
You may not qualify if…
- Uncontrolled hyperthyroidism or hypothyroidism
- Diabetes mellitus with poor glycemic control
- Adrenal gland disease
- Active inflammatory bowel disease, including Crohn's disease or ulcerative colitis
- Celiac disease
- Chronic pancreatitis
- Active gastric or esophageal disease
- Irritable bowel syndrome with significant symptoms
- History of major abdominal surgery that permanently affects gastrointestinal function, except in participants with intestinal failure when this forms part of the condition under study
- Heart failure
- Active ischemic heart disease or recent myocardial infarction
- Chronic obstructive pulmonary disease
- Respiratory failure or need for long-term oxygen therapy
- Progressive neurodegenerative disease
- Dementia impairing the ability to participate
- Severe stroke with significant functional impairment
- Active tuberculosis
- HIV/AIDS with clinically significant immunosuppression
- Active systemic autoimmune disease
- Active malignant disease
- Advanced liver cirrhosis
- Chronic kidney disease
- Treatment with hemodialysis or peritoneal dialysis
- Pregnancy or breastfeeding
Where it is running
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (enrolling)
Full record on ClinicalTrials.gov
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