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

NCT ID: NCT04147585

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2024-05-06

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.

Detailed Description

As above

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Three cycles of a 5-day Intermittent Reduced Calorie Diet

Group Type: EXPERIMENTAL

Intermittent Reduced Calorie Diet (IRCD)

Intervention Type: OTHER

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

Control Arm

Regular Diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intermittent Reduced Calorie Diet (IRCD)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sidhartha Ranjit Sinha

Assistant Professor of Medicine (Gastroenterology and Hepatology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sidhartha R Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

IRB 53161

Identifier Type: -

Identifier Source: org_study_id