Back to resultsEffects of an Intermittent Reduced Calorie Diet on Crohn's Disease
Primary Purpose
Inflammatory Bowel Diseases, Crohn Disease, Diet Modification
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Reduced Calorie Diet (IRCD)
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring IBD, Crohn's disease, Diet, Fasting, Intermittent Reduced Calorie Diet, CD, intermittent fasting, FMD
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).
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
Three cycles of a 5-day Intermittent Reduced Calorie Diet
Regular Diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants with Clinical remission as per CDAI
Defined as a CDAI score ≤ 150.
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.
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.
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.
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.
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.
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.
Patient global assessment
"Do you believe you are in remission from your CD symptoms?" (Yes/No). No scale.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04147585
Brief Title
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
Official Title
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
July 14, 2024 (Anticipated)
Study Completion Date
July 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Diet Modification
Keywords
IBD, Crohn's disease, Diet, Fasting, Intermittent Reduced Calorie Diet, CD, intermittent fasting, FMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Three cycles of a 5-day Intermittent Reduced Calorie Diet
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Regular Diet
Intervention Type
Other
Intervention Name(s)
Intermittent Reduced Calorie Diet (IRCD)
Intervention Description
Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months.
Primary Outcome Measure Information:
Title
Number of Participants with Clinical response as per CDAI (70 points)
Description
Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.
Time Frame
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 Outcome Measure Information:
Title
Number of Participants with Clinical remission as per CDAI
Description
Defined as a CDAI score ≤ 150.
Time Frame
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.
Title
Number of Participants with Clinical response as per CDAI (100 points)
Description
Defined as reduction of the CDAI of at least 100 points or achieving a CDAI score ≤ 150.
Time Frame
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.
Title
Number of Participants with Clinical response as per CDAI (70 points)
Description
Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.
Time Frame
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.
Title
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.
Description
Change of the inflammatory marker CRP if elevated at baseline.
Time Frame
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.
Title
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.
Description
Change of the inflammatory marker ESR if elevated at baseline.
Time Frame
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.
Title
Change in fecal calprotectin at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.
Description
Change of the inflammatory marker fecal calprotectin if elevated at baseline.
Time Frame
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.
Title
Number of Participants with Clinical remission as per Patient Reported Outcome (PRO) score
Description
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.
Time Frame
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.
Title
Patient global assessment
Description
"Do you believe you are in remission from your CD symptoms?" (Yes/No). No scale.
Time Frame
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.
Title
Effect of IRCD on endoscopic outcomes
Description
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.
Time Frame
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.
Title
Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)
Description
Changes in SIBDQ. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).
Time Frame
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.
Other Pre-specified Outcome Measures:
Title
Number of Participants with Clinical remission as per CDAI
Description
Defined as a CDAI score ≤ 150.
Time Frame
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.
Title
Number of Participants with Clinical response as per CDAI (100 points)
Description
Defined as reduction of the CDAI of at least 100 points or achieving a CDAI score ≤ 150.
Time Frame
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.
Title
Changes in clinical markers of disease activity
Description
Clinical markers of disease activity are CRP, ESR, and fecal calprotectin if elevated at baseline.
Time Frame
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.
Title
Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)
Description
Changes in SIBDQ. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).
Time Frame
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.
Title
Changes in clinical markers of disease activity
Description
Clinical markers of disease activity are CRP, ESR, and fecal calprotectin if elevated at baseline.
Time Frame
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.
Title
Changes in cytokines/chemokines and immune cell profiles
Description
Using flow cytometry and mass cytometry (CyTOF)
Time Frame
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.
Title
Changes in gut metabolites (including short-chain fatty acid and bile acid profiles) and microbiome profiles (using 16S rRNA/shotgun metagenomics)
Description
Gut metabolites include short-chain fatty acid and bile acid profiles.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Touran Fardeen
Phone
6507367311
Email
tfardeen@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidhartha R Sinha, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Touran Fardeen
Email
tfardeen@stanford.edu
12. IPD Sharing Statement
Learn more about this trial
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
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