Diet Modification, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
ulcerative colitis, IBD, diet, fasting, fasting mimicking diet, UC, intermittent fasting
Brief summary
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.
Interventions
5 day reduced calorie diet
OTHERRegular Diet
Regular Diet
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response as per partial Mayo score | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission as per partial Mayo score | 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. | 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. |
| Clinical remission as per modified Mayo (mMayo) score | 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. | 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. |
| Clinical response as per mMayo score | 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. | 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. |
| Patient global assessment | 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. | "Do you believe you are in remission from your UC symptoms?" (Yes/No). No scale. |
| Change in C-Reactive Protein (CRP). | 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 the inflammatory marker CRP (if elevated at baseline). |
| Change in Erythrocyte Sedimentation Rate (ESR). | 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 of the inflammatory marker ESR (if elevated at baseline). |
| Change in Fecal Calprotectin. | 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. | Change of the inflammatory marker fecal calprotectin (if elevated at baseline). |
| Symptomatic remission as per Patient Reported Outcome (PRO2) score | 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. | Defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0. |
| Effect of FMD on endoscopic outcomes | 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. | Changes in modified Mayo (mMayo) endoscopic subscore. The subscore ranges from 0 to 3 points with higher scores reflecting more severe disease. |
| Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score | 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. | 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). |
Countries
United States
Contacts
CONTACTTouran Fardeen
PRINCIPAL_INVESTIGATORSidhartha R Sinha, MD
Stanford University
Outcome results
None listed