The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615690
• Other study ID #: IRB 47075
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Touran Fardeen
• Phone: 6507367311
• Email: tfardeen[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Diet Modification
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Fasting Mimicking Diet
5 day reduced calorie diet
• Regular Diet
Regular Diet

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	Assessment of primary and key secondary endpoints at baseline versus 3 months after the start of Cycle 3.	Outcomes 1 to 11 at additional time points.	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.
Other	Changes in cytokines/chemokines and immune cell profiles using flow cytometry and mass cytometry (CyTOF).	Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, a4ß7, CCR1, and CCR9) and immune cell profiles.	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.
Other	Differences in clinical markers of disease activity at baseline versus within 6 days after completing Cycle 1.	Clinical markers of disease activity are CRP, ESR and fecal Calprotectin (if elevated at baseline).	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.
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.	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.
Primary	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.	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	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.	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	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.	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	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.	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	Patient global assessment	"Do you believe you are in remission from your UC symptoms?" (Yes/No). No scale.	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.
Secondary	Change in C-Reactive Protein (CRP).	Change in the inflammatory marker CRP (if elevated at baseline).	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.
Secondary	Change in Erythrocyte Sedimentation Rate (ESR).	Change of the inflammatory marker ESR (if elevated at baseline).	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.
Secondary	Change in Fecal Calprotectin.	Change of the inflammatory marker fecal calprotectin (if elevated at baseline).	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.
Secondary	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.	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	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.	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	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).	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.