Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease

Study Overview
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Brief Summary
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Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. CD is a common inflammatory bowel disease (IBD), frequent (150,000 patients in France and 1.5 million in Europe), disabling and incurable. The environmental factors, and in particular diet, play a major role in the pathogenesis of CD. The prevalence of CD is steadily increasing in highly industrialized countries, where the Western diet rich in saturated fats and refined sugars, is blamed for this to explain this true pandemic. On the other hand, enteral nutrition, exclusive or partial, is known to be effective in the initial treatment of CD, especially in pediatrics. There are a number of evidence in favor of a nutritional management nutritional management of caloric restriction during inflammatory diseases such as psoriasis and rheumatoid arthritis,whose physiopathology is similar to that of IBD. To date, and despite patient concern, there is no consensus nutritional in the management of CD to influence the natural course of the disease. The investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric restriction in patients with CD.

Official Title
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Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: Intermittent caloric restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 to 65 years old Established diagnosis of Crohn's disease with a minimum disease duration of 3 months Patient with mild to moderate Crohn's disease defined by a fecal calprotectin ≥ 250 μg/g and a CDAI score between 150 to 300 Medical treatment of Crohn's disease stable for at least 3 months Patient compliant with an intermittent caloric restriction during 16 weeks Person affiliated to or beneficiary of a social security plan Person informed about study organization and having signed the informed consent Exclusion Criteria: Patient with a BMI < 18.5kg/m2 Patient having a weight loss of 5% the first month and 10% during the first 6 months Patient with active ano-perineal lesions Patient with an ostomy Patient with eating disorders (anorexia, bulimia) Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code: Pregnant, parturient or breastfeeding woman Minor person (non-emancipated) Adult person under legal protection (any form of public guardianship) Adult person incapable of giving consent and not under legal protection Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent caloric restriction<br>Intermittent caloric restriction during 16 weeks. | Other: Intermittent caloric restriction<br>* Intermittente caloric restriction: st month: restriction of 50% of the caloric intake previously determined by the dietician 1 day per week nd month: restriction of 50% of the caloric intake 2 days per week rd month: restriction of 60% of the caloric intake 2 days per week th month: restriction of 75% of the caloric intake 2 days per week<br>|
| No Intervention: Routine practice<br>Routine practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal inflammation | Evaluate the effectiveness of personalized nutritional management of intermittent caloric restriction during 16 weeks on the level of intestinal inflammation (induction of of a biological response) in patients with mild to moderate CD mild to moderate. The effectiveness will be evaluated in each group by a biological response change, that is to say a decrease at least 50% of calprotectin fecal level. | week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of a clinical response | Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on Crohn's Disease Activity Index (CDAI) that is to say change by al least 100 points. The following cut-offs correlate with level of disease activity: Non-active disease: CDAI < 150 Mild disease activity: CDAI >= 150 and <220 Moderate disease activity: CDAI >= 220 and <450 Severe disease activity: CDAI > 450 | week 16 | 
| Induction of a clinical remission | Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on clinical remission, that is to say Crohn's Disease Activity Index (CDAI) < 150 The following cut-offs correlate with level of disease activity: Non-active disease: CDAI < 150 Mild disease activity: CDAI >= 150 and <220 Moderate disease activity: CDAI >= 220 and <450 Severe disease activity: CDAI > 450 | week 16 | 
| Induction of a biological remission | Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on biological remission that is to say fecal calprotection < 250 µg/g | week 16 | 
| Induction of a radiological response | Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on radiological response that is to say change of 50% of Nancy score measured by magnetic resonance imaging (MRI) Total MRI score: 0 at 36 | week 16 | 
| Improving quality of life | Evaluated by short-Inflammatory Bowel Disease Questionnaire (short-IBDQ) short-IBDQ is a 10-items measure that assesses self-reported quality of life. Total score ranges from 10 to 70. Higher the score is better life quality is. | week 16 | 
| Improving work productivity | Evaluated by Work Productivity and Activity Impairment Questionnaire (WPAI) WPAI questions measure the effect of patients health problems (any physical or emotional problem or symptom) on their ability to work and perform regular activites. | week 16 | 
| Improving fatigue | Evaluated by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) FACIT-F is a 40-items measure that assesses self-reported fatigue and its impact upon daily activities and function. | week 16 | 
| Improving functional disability | Evaluated by Inflammatory Bowel Disease - Disability Index (IBD-DI) IBD-DI is a 14-items measure that assesses self-reported disability. It ranges from 0-100: 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability) and 50-100 (severe disability) | week 16 | 
| Improving anxiety disorder | Evaluated by Generalized Anxiety Disorder (GAD-7) The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety | week 16 | 
| Evaluate the safety of intermittent caloric restriction in patients with mild to moderate with mild to moderate CD. | Percentage of adverse event related to intermittent caloric restriction (fatigue; nausea; headache, dizziness, hypotension, irritability, capacity reduced to concentrating, undernutrition/sarcopenia) | weeks 4;8;12 and 16 | 
| Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD. | Percentage of patient compliance measured by for example a intermittent caloric restriction during at least 21 days on the 16 weeks of the study | week 16 | 
| Determine the level of patient satisfaction with intermittent caloric restriction | Evaluated by Likert scale at 4 items ad-hoc 4 point likert scale for the frequency; assign each response a point value from 1 to 4. | week 16 | 
| Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction | Percentage of patients having a compensatory hyperphagia after 2 days of intermittent caloric restriction. | 48 hours after intermittent caloric restriction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermittent caloric restriction, Crohn's disease