Back to resultsThe Influence of a Fasting Mimicking Diet on Ulcerative Colitis
Primary Purpose
Inflammatory Bowel Disease, Diet Modification, Ulcerative Colitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fasting Mimicking Diet
Regular Diet
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring ulcerative colitis, IBD, diet, fasting, fasting mimicking diet, UC, intermittent fasting
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7)
- Age of 18-70 at start of study (inclusive)
Exclusion Criteria:
- Women who are pregnant or 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 as defined by the patient's physician, 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 FMD 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 caloric 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, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fasting Mimicking Diet
Regular Diet Control Arm
Arm Description
Three cycles of a 5-day reduced calorie diet
Outcomes
Primary Outcome Measures
Clinical response as per partial Mayo score
Defined as a decrease from baseline in the partial Mayo score of >= 2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point, or achieving a partial Mayo score <2. The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy.
Secondary Outcome Measures
Clinical remission as per partial Mayo score
Defined as a partial Mayo score < 2 points. The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy.
Clinical remission as per modified Mayo (mMayo) score
Defined as mMayo score <= 1 point, with rectal bleeding and stool frequency subscore of 0, and endoscopy subscore of 0 or 1. The mMayo score consists of the subscores for stool frequency, rectal bleeding, and endoscopy, omitting PGA.
Clinical response as per mMayo score
Defined as a decrease of the mMayo score of >=2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point.
Patient global assessment
"Do you believe you are in remission from your UC symptoms?" (Yes/No). No scale.
Change in C-Reactive Protein (CRP).
Change in the inflammatory marker CRP (if elevated at baseline).
Change in Erythrocyte Sedimentation Rate (ESR).
Change of the inflammatory marker ESR (if elevated at baseline).
Change in Fecal Calprotectin.
Change of the inflammatory marker fecal calprotectin (if elevated at baseline).
Effect of FMD on endoscopic outcomes
Changes in modified Mayo (mMayo) endoscopic subscore. The subscore ranges from 0 to 3 points with higher scores reflecting more severe disease.
Symptomatic remission as per Patient Reported Outcome (PRO2) score
Defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0.
Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score
Quality of life score in UC patients. 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
NCT03615690
Brief Title
The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
Official Title
The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 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 a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC). 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 UC are very limited. Fasting mimicking diets (FMD) 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 three cycles of a five-day period of the fasting mimicking diet, and may provide rationale for its use to treat UC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Diet Modification, Ulcerative Colitis
Keywords
ulcerative colitis, IBD, diet, fasting, fasting mimicking diet, UC, intermittent fasting
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
Fasting Mimicking Diet
Arm Type
Experimental
Arm Description
Three cycles of a 5-day reduced calorie diet
Arm Title
Regular Diet Control Arm
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Fasting Mimicking Diet
Intervention Description
5 day reduced calorie diet
Intervention Type
Other
Intervention Name(s)
Regular Diet
Intervention Description
Regular Diet
Primary Outcome Measure Information:
Title
Clinical response as per partial Mayo score
Description
Defined as a decrease from baseline in the partial Mayo score of >= 2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point, or achieving a partial Mayo score <2. The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy.
Time Frame
Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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
Clinical remission as per partial Mayo score
Description
Defined as a partial Mayo score < 2 points. The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy.
Time Frame
Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.
Title
Clinical remission as per modified Mayo (mMayo) score
Description
Defined as mMayo score <= 1 point, with rectal bleeding and stool frequency subscore of 0, and endoscopy subscore of 0 or 1. The mMayo score consists of the subscores for stool frequency, rectal bleeding, and endoscopy, omitting PGA.
Time Frame
Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.
Title
Clinical response as per mMayo score
Description
Defined as a decrease of the mMayo score of >=2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point.
Time Frame
Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 UC symptoms?" (Yes/No). No scale.
Time Frame
Assessed within 6 days after completing Cycle 3. 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).
Description
Change in the inflammatory marker CRP (if elevated at baseline).
Time Frame
Comparison of CRP levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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).
Description
Change of the inflammatory marker ESR (if elevated at baseline).
Time Frame
Comparison of ESR levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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.
Description
Change of the inflammatory marker fecal calprotectin (if elevated at baseline).
Time Frame
Comparison of calprotectin levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 FMD on endoscopic outcomes
Description
Changes in modified Mayo (mMayo) endoscopic subscore. The subscore ranges from 0 to 3 points with higher scores reflecting more severe disease.
Time Frame
Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.
Title
Symptomatic remission as per Patient Reported Outcome (PRO2) score
Description
Defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0.
Time Frame
Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 Short Inflammatory Bowel Disease questionnaire (SIBDQ) score
Description
Quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).
Time Frame
Comparison of SIBDQ score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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
Assessment of primary and key secondary endpoints at baseline versus 3 months after the start of Cycle 3.
Description
Outcomes 1 to 11 at additional time points.
Time Frame
Comparison of endpoints up to 14 days before starting Cycle 1, and 3 months after the start of Cycle 3. 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 using flow cytometry and mass cytometry (CyTOF).
Description
Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.
Time Frame
Comparison of cytokines/chemokines/immune cell profiles up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.
Title
Differences in clinical markers of disease activity at baseline versus within 6 days after completing Cycle 1.
Description
Clinical markers of disease activity are CRP, ESR and fecal Calprotectin (if elevated at baseline).
Time Frame
Comparison of clinical markers up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 1. 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
Comparison of characteristics up to 14 days before Cycle 1, within 6 days after completing Cycle 3, and 3 months after start of Cycle 3. 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 Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7)
Age of 18-70 at start of study (inclusive)
Exclusion Criteria:
Women who are pregnant or 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 as defined by the patient's physician, 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 FMD 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 caloric 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, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.
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
The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
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