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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04147585
• Other study ID #: IRB 53161
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: July 14, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As above

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: July 14, 2024
• Est. primary completion date: July 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease
• Diet Modification
• Inflammatory Bowel Diseases

Intervention

Other:
• Intermittent Reduced Calorie Diet (IRCD)
Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Number of Participants with Clinical response as per CDAI (100 points)	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.
Other	Changes in clinical markers of disease activity	Clinical markers of disease activity are CRP, ESR, and fecal calprotectin if elevated at baseline.	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.
Other	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.
Other	Changes in clinical markers of disease activity	Clinical markers of disease activity are CRP, ESR, and fecal calprotectin if elevated at baseline.	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.
Other	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.
Other	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.
Primary	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	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.
Secondary	Number of Participants with Clinical response as per CDAI (100 points)	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.
Secondary	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.
Secondary	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 if elevated at baseline.	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.
Secondary	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 if elevated at baseline.	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.
Secondary	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 if elevated at baseline.	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.