Clinical trial NCT03054935: Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease
Official title: The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Keywords: Energy Expenditure
Body Composition
Food Intake
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: Fabiana Castiglione
First posted: 2017-02-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending Gastroenterology Unit

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease
timeFrame: At baseline
Secondary outcomes:
measure: Body composition assessment by bioelectrical impedence analysis (BIA)
timeFrame: At baseline
measure: Assessment of muscle function by hand-grip strength
timeFrame: At baseline
measure: Food intake evaluation
timeFrame: At baseline
measure: Inflammatory biomarkers
timeFrame: At baseline
measure: Quality of Life (QoL)
timeFrame: At baseline
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Federico II University Hospital
Study officials:
References:
citation: Al-Jaouni R, Hebuterne X, Pouget I, Rampal P. Energy metabolism and substrate oxidation in patients with Crohn's disease. Nutrition. 2000 Mar;16(3):173-8. doi: 10.1016/s0899-9007(99)00281-6.
citation: Gong J, Zuo L, Guo Z, Zhang L, Li Y, Gu L, Zhao J, Cao L, Zhu W, Li N, Li J. Impact of Disease Activity on Resting Energy Expenditure and Body Composition in Adult Crohn's Disease: A Prospective Longitudinal Assessment. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):713-8. doi: 10.1177/0148607114528360. Epub 2014 Mar 25.
citation: Kushner RF, Schoeller DA. Resting and total energy expenditure in patients with inflammatory bowel disease. Am J Clin Nutr. 1991 Jan;53(1):161-5. doi: 10.1093/ajcn/53.1.161.
citation: Rigaud D, Cerf M, Angel Alberto L, Sobhani I, Carduner MJ, Mignon M. [Increase of resting energy expenditure during flare-ups in Crohn disease]. Gastroenterol Clin Biol. 1993;17(12):932-7. French.
citation: Schneeweiss B, Lochs H, Zauner C, Fischer M, Wyatt J, Maier-Dobersberger T, Schneider B. Energy and substrate metabolism in patients with active Crohn's disease. J Nutr. 1999 Apr;129(4):844-8. doi: 10.1093/jn/129.4.844.
citation: Vaisman N, Dotan I, Halack A, Niv E. Malabsorption is a major contributor to underweight in Crohn's disease patients in remission. Nutrition. 2006 Sep;22(9):855-9. doi: 10.1016/j.nut.2006.05.013.