Resting Energy Expenditure by Gastrointestinal Functional Status

NCT07714499 | Recruiting

• 1 other identifier: ORI2025-12
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Failure; Short Bowel Syndrome

Keywords

Resting Energy Expenditure; Indirect Calorimetry; Body Composition; Dual-Energy X-Ray Absorptiometry

Outcome Measures

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.

  During the single study visit; REE is assessed over approximately 30 minutes

Secondary Outcomes (7)

• Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry

  During the single study visit, lasting approximately 90 to 120 minutes

• Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry

  During the single study visit, lasting approximately 90 to 120 minutes

• Phase Angle Assessed by Bioelectrical Impedance Analysis

  During the single study visit, lasting approximately 90 to 120 minutes

• C-Reactive Protein

  During the single study visit, lasting approximately 90 to 120 minutes

• Neutrophil-to-Lymphocyte Ratio

  During the single study visit, lasting approximately 90 to 120 minutes

Study Arms (2)

Healthy Controls

ACTIVE COMPARATOR

Adults with normal gastrointestinal function who serve as the comparison group. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.

Diagnostic Test: Protocol-Defined Metabolic and Body Composition Assessment

Participants With Intestinal Failure

EXPERIMENTAL

Adults with clinically confirmed intestinal failure, including participants with short bowel syndrome and participants with other causes of intestinal failure. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.

Diagnostic Test: Protocol-Defined Metabolic and Body Composition Assessment

Interventions

Protocol-Defined Metabolic and Body Composition Assessment DIAGNOSTIC_TEST

Participants 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.

Healthy Controls; Participants With Intestinal Failure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Intestinal Failure; Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Klemen Schara, MSc

CONTACT

+38631630065; kschara@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are enrolled non-randomly into one of two parallel groups based on their pre-existing gastrointestinal functional status: healthy controls with normal gastrointestinal function and patients with intestinal failure. Both groups undergo the same protocol-defined assessments during a single study visit, including indirect calorimetry, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

SL (1)