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Resting Energy Expenditure by Gastrointestinal Functional Status

2026년 7월 15일 업데이트: Institute of Oncology Ljubljana

Comparison of Resting Energy Expenditure According to Gastrointestinal Functional Status

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.

연구 개요

상세 설명

Intestinal failure is a condition in which the gastrointestinal tract is unable to provide adequate digestion and absorption of nutrients, electrolytes, and fluids. Patients may therefore require partial or complete parenteral nutrition. Their resting energy expenditure may be affected by the underlying cause of intestinal failure, changes in body composition, nutritional and metabolic status, and systemic inflammation. Accurate assessment of energy requirements is important for planning individualized nutritional support.

This is a prospective, comparative interventional study with two non-randomized, protocol-defined groups. Group A will include 30 healthy adults with normal gastrointestinal function. Group B will include 62 clinically stable patients with confirmed intestinal failure. Within Group B, approximately 38 participants will have short bowel syndrome and 24 will have other causes of type II or type III intestinal failure, including chronic intestinal dysmotility or extensive disease of the small intestinal mucosa.

The study intervention consists of metabolic, body-composition, and laboratory assessments performed according to a standardized research protocol. Each participant will complete the study during one visit at the Institute of Oncology Ljubljana. The visit will last approximately 90 to 120 minutes. Resting energy expenditure will be measured in the morning, after fasting, in a thermoneutral environment using indirect calorimetry. The indirect calorimetry measurement will last approximately 30 minutes and will determine oxygen consumption and carbon dioxide production.

Body composition will be assessed using dual-energy X-ray absorptiometry to measure lean body mass, fat mass, and bone mineral density. Bioelectrical impedance analysis will also be performed to determine phase angle as an indicator of cellular integrity and function. A blood sample will be collected to assess inflammatory markers, including C-reactive protein and calculated neutrophil-to-lymphocyte, platelet-to-lymphocyte, and lymphocyte-to-monocyte ratios.

Resting energy expenditure will be evaluated as an absolute value in kilocalories per day and in standardized forms, including adjustment for lean body mass, age, and sex. The primary analyses will compare resting energy expenditure between healthy participants and patients with intestinal failure and between patients with short bowel syndrome and patients with other causes of intestinal failure.

Secondary analyses will examine the associations between resting energy expenditure and body-composition parameters, phase angle, and inflammatory markers. The study is intended to improve understanding of metabolic requirements in intestinal failure and to support the development of more individualized nutritional recommendations for these patients.

연구 유형

중재적

등록 (추정된)

92

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Ljubljana, 슬로베니아, 1000
        • 모병
        • Institute of Oncology Ljubljana
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Healthy Controls
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.
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.
실험적: Participants With Intestinal Failure
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Resting Energy Expenditure Measured by Indirect Calorimetry
기간: During the single study visit; REE is assessed over approximately 30 minutes
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

2차 결과 측정

결과 측정
측정값 설명
기간
Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry
기간: During the single study visit, lasting approximately 90 to 120 minutes
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.
During the single study visit, lasting approximately 90 to 120 minutes
Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry
기간: During the single study visit, lasting approximately 90 to 120 minutes
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.
During the single study visit, lasting approximately 90 to 120 minutes
Phase Angle Assessed by Bioelectrical Impedance Analysis
기간: During the single study visit, lasting approximately 90 to 120 minutes
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.
During the single study visit, lasting approximately 90 to 120 minutes
C-Reactive Protein
기간: During the single study visit, lasting approximately 90 to 120 minutes
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.
During the single study visit, lasting approximately 90 to 120 minutes
Neutrophil-to-Lymphocyte Ratio
기간: During the single study visit, lasting approximately 90 to 120 minutes
The neutrophil-to-lymphocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
During the single study visit, lasting approximately 90 to 120 minutes
Platelet-to-Lymphocyte Ratio
기간: During the single study visit, lasting approximately 90 to 120 minutes
The platelet-to-lymphocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
During the single study visit, lasting approximately 90 to 120 minutes
Lymphocyte-to-Monocyte Ratio
기간: During the single study visit, lasting approximately 90 to 120 minutes
The lymphocyte-to-monocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
During the single study visit, lasting approximately 90 to 120 minutes

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 1일

기본 완료 (추정된)

2026년 10월 1일

연구 완료 (추정된)

2026년 10월 1일

연구 등록 날짜

최초 제출

2026년 7월 15일

QC 기준을 충족하는 최초 제출

2026년 7월 15일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 15일

마지막으로 확인됨

2026년 7월 1일

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