Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease (REECD)

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

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)

Study Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Indirect Calorimetry

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Fabrizio Pasanisi, MD, PhD; Phone Number: +39 081 7464747; Email: pasanisi@unina.it

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Federico II University Hospital
    • Contact: Fabrizio Pasanisi, MD, PhD; Phone Number: +39 0817464747; Email: pasanisi@unina.it
    • Contact: Iolanda Cioffi, PhD; Phone Number: +39 081 7462333; Email: iolanda.cioffi@unina.it
    • Sub-Investigator: Fabiana Castiglione, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients attending Gastroenterology Unit

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subject-CD; 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; Measurement of resting energy expenditure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fabrizio Pasanisi
• Collaborators: Fabiana Castiglione

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Body Composition; Food Intake; Energy Expenditure
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 102/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No