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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting Mimicking Diet | Experimental | Three cycles of a 5-day reduced calorie diet |
|
| Regular Diet Control Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting Mimicking Diet | Other | 5 day reduced calorie diet |
| |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of primary and key secondary endpoints at baseline versus 3 months after the start of Cycle 3. | Outcomes 1 to 11 at additional time points. | Comparison of endpoints up to 14 days before starting Cycle 1, and 3 months after the start of 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Touran Fardeen | Contact | 6507367311 | tfardeen@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sidhartha R Sinha, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Regular Diet |
| Other |
Regular Diet |
|
| 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. |
| Changes in cytokines/chemokines and immune cell profiles using flow cytometry and mass cytometry (CyTOF). | Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles. | Comparison of cytokines/chemokines/immune cell profiles 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. |
| Differences in clinical markers of disease activity at baseline versus within 6 days after completing Cycle 1. | Clinical markers of disease activity are CRP, ESR and fecal Calprotectin (if elevated at baseline). | Comparison of clinical markers up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 1. 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 gut metabolites (including short-chain fatty acid and bile acid profiles) and microbiome profiles (using 16S rRNA/shotgun metagenomics). | Gut metabolites include short-chain fatty acid and bile acid profiles. | Comparison of characteristics up to 14 days before Cycle 1, within 6 days after completing Cycle 3, and 3 months after start of 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. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |