Resting Energy Expenditure by Gastrointestinal Functional Status
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Oncology Ljubljana
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 65 years
No diagnosed chronic diseases
No hospitalization within the previous 30 days
No acute illness within the previous 14 days
Disqualifiers
Uncontrolled hyperthyroidism or hypothyroidism
Diabetes mellitus with poor glycemic control
Adrenal gland disease
Active inflammatory bowel disease, including Crohn's disease or ulcerative colitis
Trial design
Design model
Parallel
Treatments tested in this trial
Protocol-Defined Metabolic and Body Composition Assessment
Diagnostic testParticipants undergo a standardized research assessment during one study visit. Resting energy expenditure is measured by indirect calorimetry after fasting. Body composition is assessed by dual-energy X-ray absorptiometry and bioelectrical impedance analysis. Blood samples are collected for the assessment of inflammatory markers. These assessments are performed outside routine clinical care according to the study protocol.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Healthy ControlsActive comparator 1 intervention
Group B: Participants With Intestinal FailureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Resting Energy Expenditure Measured by Indirect Calorimetry
Resting energy expenditure (REE) will be measured by indirect calorimetry in the morning after fasting and under thermoneutral conditions. The measurement will last approximately 30 minutes and REE will be expressed as an absolute value in kilocalories per day. REE will also be standardized according to lean body mass and evaluated according to age and sex. Values will be compared between healthy controls and participants with intestinal failure, as well as between participants with short bowel syndrome and participants with other causes of intestinal failure.
Time frame
During the single study visit; REE is assessed over approximately 30 minutesSecondary outcomes
1
Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry
Lean body mass will be measured by dual-energy X-ray absorptiometry (DXA). The association between lean body mass and resting energy expenditure will be analyzed in all participants.
Time frame
During the single study visit, lasting approximately 90 to 120 minutes2
Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry
Fat mass will be measured by dual-energy X-ray absorptiometry (DXA). The association between fat mass and resting energy expenditure will be analyzed in all participants.
Time frame
During the single study visit, lasting approximately 90 to 120 minutes3
Phase Angle Assessed by Bioelectrical Impedance Analysis
Phase angle will be measured by bioelectrical impedance analysis (BIA) as an indicator of cellular integrity and function. The association between phase angle and resting energy expenditure will be analyzed in healthy controls and participants with intestinal failure.
Time frame
During the single study visit, lasting approximately 90 to 120 minutes4
C-Reactive Protein
C-reactive protein concentration will be determined from a blood sample as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
Time frame
During the single study visit, lasting approximately 90 to 120 minutesSponsors and contacts
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Source ClinicalTrials.gov