Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect disease activity on resting energy expenditure (REE), body composition, inflammatory markers, food intake and quality of life in subjects affected by Crohn's Disease (CD)

Detailed Description
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Malnutrition is a common sequel among patients affected by Crohn's disease (CD). The pathogenic mechanisms include poor dietary intake, increased resting energy expenditure (REE), nutrient malabsorption and loss. So far, few studies have been carried out in CD adult patients, assessing the effect of disease activity on both REE and body composition. Vaisman et al (2006) studied sixteen CD patients in remission (> 3 mo) and showed no effect of REE on lower BMI, although in the presence of similar energy intake in according with previous studies (Al-Jaouni et al., 2000; Schneeweiss et al., 1999). While, Gong et al., 2015 found that patients with active disease had an increase in REE compared to patients in remission as already shown by Rigaud et al., 1993; Kushner and Schoeller, 1991. Overall, the effect of disease activity on REE is still uncertain and requires further investigation.

Official Title
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The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: Indirect Calorimetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Crohn's Disease Exclusion Criteria: Comorbidity affecting energy metabolism (diabetes mellitus, thyroid dysfunction, etc.) History of acute or chronic liver or kidney disease Current parenteral nutrition Presence of fistulae, ileostomy or colostomy Presence of extensive small bowel resection (residual small bowel < 2 meters) Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject-CD<br>Subjects with Crohn's Disease in active or quiescent phase, classified according to Crohn's Disease Activity Index (CDAI >150 active; CDAI < 150 quiescent) | Other: Indirect Calorimetry<br>* Measurement of resting energy expenditure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease | The measurement of REE by IC is a non-invasive method that measures oxygen consumption and carbon dioxide production and it is generally considered the gold standard in clinical practice. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition assessment by bioelectrical impedence analysis (BIA) |  | At baseline | 
| Assessment of muscle function by hand-grip strength | Hand-grip strength will be performed by dynamometer | At baseline | 
| Food intake evaluation | Food intake will be assessed by filling 3 day food records | At baseline | 
| Inflammatory biomarkers | Serum concentration of high sensitive C-reactive protein (hs-RCP) will be determined by immunoturbidimetric assay while tumor necrosis factor - alpha (TNF-alpha) and Interleukin 6 (IL-6) will be assessed by ELISA. | At baseline | 
| Quality of Life (QoL) | Assessment of each patient's health and well-being using the short-form 36 (SF-36). | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy Expenditure, Body Composition, Food Intake