The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC). 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 UC are very limited. Fasting mimicking diets (FMD) 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 three cycles of a five-day period of the fasting mimicking diet, and may provide rationale for its use to treat UC.

Official Title
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The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Conditions
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Inflammatory Bowel Disease, Diet Modification, Ulcerative Colitis

Intervention / Treatment
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* Other: Fasting Mimicking Diet
* Other: Regular Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7) Age of 18-70 at start of study (inclusive) Exclusion Criteria: Women who are pregnant or 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 as defined by the patient's physician, 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 FMD 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 caloric 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, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting Mimicking Diet<br>Three cycles of a 5-day reduced calorie diet | Other: Fasting Mimicking Diet<br>* 5 day reduced calorie diet<br>|
| Placebo Comparator: Regular Diet Control Arm<br> | Other: Regular Diet<br>* Regular Diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response as per partial Mayo score | Defined as a decrease from baseline in the partial Mayo score of >= 2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point, or achieving a partial Mayo score <2. The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy. | Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 |
| --- | --- | --- |
| Clinical remission as per partial Mayo score | Defined as a partial Mayo score < 2 points. The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy. | Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Clinical remission as per modified Mayo (mMayo) score | Defined as mMayo score <= 1 point, with rectal bleeding and stool frequency subscore of 0, and endoscopy subscore of 0 or 1. The mMayo score consists of the subscores for stool frequency, rectal bleeding, and endoscopy, omitting PGA. | Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Clinical response as per mMayo score | Defined as a decrease of the mMayo score of >=2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point. | Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 UC symptoms? (Yes/No). No scale. | Assessed within 6 days after completing Cycle 3. 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). | Change in the inflammatory marker CRP (if elevated at baseline). | Comparison of CRP levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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). | Change of the inflammatory marker ESR (if elevated at baseline). | Comparison of ESR levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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. | Change of the inflammatory marker fecal calprotectin (if elevated at baseline). | Comparison of calprotectin levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 FMD on endoscopic outcomes | Changes in modified Mayo (mMayo) endoscopic subscore. The subscore ranges from 0 to 3 points with higher scores reflecting more severe disease. | Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. | 
| Symptomatic remission as per Patient Reported Outcome (PRO2) score | Defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0. | Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 Short Inflammatory Bowel Disease questionnaire (SIBDQ) score | Quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best). | Comparison of SIBDQ score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, IBD, diet, fasting, fasting mimicking diet, UC, intermittent fasting