Resting Energy Expenditure by Gastrointestinal Functional Status (NCT07714499) | Clinical Trial Compass
RecruitingNot Applicable
Resting Energy Expenditure by Gastrointestinal Functional Status
Slovenia92 participantsStarted 2025-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resting Energy Expenditure Measured by Indirect Calorimetry
Timeframe: During the single study visit; REE is assessed over approximately 30 minutes