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The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting (also known as a fasting mimicking diet, FMD) 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.
As above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Three cycles of a 5-day Intermittent Reduced Calorie Diet |
|
| Control Arm | No Intervention | Regular Diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Reduced Calorie Diet (IRCD) | Other | Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months. |
|
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinical remission as per CDAI | Defined as 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. |
| Number of Participants with Clinical response as per CDAI (100 points) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sidhartha R Sinha, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41530382 | Derived | Kulkarni C, Fardeen T, Gubatan J, Ye J, Jarr K, Dickson E, Jang H, Temby M, Patel A, Jiang Y, Singh G, Keyashian K, Streett S, Ho E, Barber G, Singh S, Limsui D, Anaizi N, Becker L, Spencer SP, Mehrish D, Perelman D, Longo VD, Charu V, Ashouri JF, Davis MM, Habtezion A, Sonnenburg JL, Gardner C, Sinha SR. A fasting-mimicking diet in patients with mild-to-moderate Crohn's disease: a randomized controlled trial. Nat Med. 2026 Mar;32(3):1023-1033. doi: 10.1038/s41591-025-04173-w. Epub 2026 Jan 13. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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. | 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. | 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. | 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. |
Defined as reduction of the CDAI of at least 100 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. |
| Changes in clinical markers of disease activity | Clinical markers of disease activity are CRP, ESR, and fecal calprotectin. | At baseline versus 3 months 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 3 months 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. |
| Changes in clinical markers of disease activity | Clinical markers of disease activity are CRP, ESR, and fecal calprotectin. | At baseline versus within 6 days after 1st 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. |
| Changes in cytokines/chemokines and immune cell profiles | Using flow cytometry and mass cytometry (CyTOF) | At 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. |
| 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. | At baseline versus within 6 days after 3rd cycle of IRCD and 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. |
| D005247 | Feeding Behavior |
| D001519 | Behavior |