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

NCT04147585 | Completed

• 1 other identifier: IRB 53161
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Diet Modification

Keywords

IBD; Crohn's disease; Diet; Fasting; Intermittent Reduced Calorie Diet; CD; intermittent fasting; FMD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of Participants with Clinical remission as per CDAI

  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)

  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)

  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.

  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.

  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.

Other Outcomes (7)

• Number of Participants with Clinical remission as per CDAI

  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)

  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

  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.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Three cycles of a 5-day Intermittent Reduced Calorie Diet

Other: Intermittent Reduced Calorie Diet (IRCD)

Control Arm

NO INTERVENTION

Regular Diet

Interventions

Intermittent Reduced Calorie Diet (IRCD) OTHER

Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate Crohn's disease (CDAI score 151-450)
• Between the ages of 18-70 (inclusive)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• 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 Jan 13. doi: 10.1038/s41591-025-04173-w. Online ahead of print.

  PMID: 41530382 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Fasting; Intermittent Fasting

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Feeding Behavior; Behavior

Study Officials

• Sidhartha R Sinha, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Gastroenterology and Hepatology)

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 1, 2019
• Study Start: December 18, 2019
• Primary Completion: March 12, 2024
• Study Completion: May 6, 2024
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)