Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD.

Detailed Description
-----------------
As above

Official Title
-----------------
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease

Conditions
-----------------
Inflammatory Bowel Diseases, Crohn Disease, Diet Modification

Intervention / Treatment
-----------------
* Other: Intermittent Reduced Calorie Diet (IRCD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate Crohn's disease (CDAI score 151-450) Between the ages of 18-70 (inclusive) Exclusion Criteria: Women who are pregnant, nursing or expect to be pregnant Individuals allergic to nuts Individuals with a body mass index (BMI) lower than 18 Individuals diagnosed with a serious medical condition (unless approved in writing by a physician) Individuals who have been severely weakened by a disease or medical procedure Individuals who are taking medication which may not be safely consumed with a calorie restricted diet Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemia Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40%) Individuals with a history of syncope Individuals with dietary needs incompatible with the IRCD meal plan Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet Patients on a calorie restricted diet will also be excluded Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine,total colectomy, proctocolectomy, ileoanal pouch will be excluded (not excluded are patients with resection of terminal ileum, resection of short strictures of the small intestine, hemicolectomy).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Three cycles of a 5-day Intermittent Reduced Calorie Diet | Other: Intermittent Reduced Calorie Diet (IRCD)<br>* Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months.<br>|
| No Intervention: Control Arm<br>Regular Diet | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Clinical response as per CDAI (70 points) | Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150. | Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Clinical remission as per CDAI | Defined as a CDAI score ≤ 150. | Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Number of Participants with Clinical response as per CDAI (100 points) | Defined as reduction of the CDAI of at least 100 points or achieving a CDAI score ≤ 150. | Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Number of Participants with Clinical response as per CDAI (70 points) | Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150. | Assessed 3 months after 3rd cycle. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Change in C-reactive protein (CRP) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group. | Change of the inflammatory marker CRP if elevated at baseline. | Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Change in Erythrocyte Sedimentation Rate (ESR) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group. | Change of the inflammatory marker ESR if elevated at baseline. | Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Change in fecal calprotectin at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group. | Change of the inflammatory marker fecal calprotectin if elevated at baseline. | Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Number of Participants with Clinical remission as per Patient Reported Outcome (PRO) score | Defined as average worst daily abdominal pain score of ≤ 1 (using a 4-point scale, 0-3) and a loose/watery stool (Bristol Type 6 or 7) frequency score of <=3. | Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Patient global assessment | Do you believe you are in remission from your CD symptoms? (Yes/No). No scale. | Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Effect of IRCD on endoscopic outcomes | Changes in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD). SES-CD scores range from 0 to 56 and higher scores indicate more severe disease. | Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ) | Changes in SIBDQ. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best). | Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, Crohn's disease, Diet, Fasting, Intermittent Reduced Calorie Diet, CD, intermittent fasting, FMD