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

Not Applicable

Active, not recruiting

• Conditions: Crohn Disease; Diet Modification; Inflammatory Bowel Diseases
• Interventions: Other: Intermittent Reduced Calorie Diet (IRCD)

• Registration Number: NCT04147585
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting 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.

Detailed Description

As above

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-11-01
• Study Start: 2019-12-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-01-14
• Study Completion: 2025-01-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

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

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Intermittent Reduced Calorie Diet (IRCD)	Three cycles of a 5-day Intermittent Reduced Calorie Diet

Primary Outcome Measures

Name	Time	Method
Number of Participants with Clinical response as per CDAI (70 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.	Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.

Secondary Outcome Measures

Name	Time	Method
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 of the inflammatory marker CRP if elevated at baseline.
Change in fecal calprotectin 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 of the inflammatory marker fecal calprotectin if elevated at baseline.
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.	Defined as reduction of the CDAI of at least 100 points or achieving a CDAI score ≤ 150.
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.	Defined as a CDAI score ≤ 150.
Patient global assessment	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.	"Do you believe you are in remission from your CD symptoms?" (Yes/No). No scale.
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.	Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.
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.	Change of the inflammatory marker ESR if elevated at baseline.
Effect of IRCD on endoscopic outcomes	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.	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.
Number of Participants with Clinical remission as per Patient Reported Outcome (PRO) score	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 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.
Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)	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.	Changes in SIBDQ. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States