Diet Modification · Inflammatory Bowel Disease · Ulcerative Colitis
Fasting-Mimicking Diet Study for Mild to Moderate Ulcerative Colitis
This study is investigating whether three monthly cycles of a five-day fasting-mimicking diet affect inflammation, ulcerative colitis disease measures, or quality of life in adults with mild to moderate disease.
Registry title: The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–70 Years
- Treatment
- Fasting Mimicking Diet or Regular Diet
- Design
- Randomized
- Central study contact
- Touran Fardeen6507367311tfardeen@stanford.edu
- Sponsor
- Stanford University
Research question
Does completing three monthly five-day cycles of a fasting-mimicking diet change inflammation markers, ulcerative colitis disease measures, or quality of life compared with following a regular diet?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 70 at the start of the study.
- The study is looking for people with mild to moderate ulcerative colitis and a partial Mayo score from 2 through 7 out of 9.
- The registry states that people of all sexes may be enrolled.
- The registry lists one recruiting location at Stanford University in Palo Alto, California.
Participation overview
What participation may involve
Participants are randomly assigned either to complete three monthly five-day reduced-calorie diet cycles or to follow a regular diet. Disease measures, inflammation markers, quality of life, immune profiles, and microbiome-related outcomes are assessed at reported time points. What participation may involve: - Follow the assigned fasting-mimicking diet or regular diet. - Complete ulcerative colitis disease assessments based on stool frequency, rectal bleeding, physician global assessment, and patient-reported symptoms. - Have inflammatory markers assessed, including C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin when elevated at baseline. - Complete the Short Inflammatory Bowel Disease Questionnaire and a yes-or-no patient global assessment about remission. - Undergo assessments of endoscopic disease scores, immune profiles, gut metabolites, and microbiome profiles at reported study time points. The fasting-mimicking intervention consists of three five-day cycles given once a month. Some outcomes are also assessed three months after the start of Cycle 3.
Study interventions
What participants may receive or do
- Fasting Mimicking Diet: Participants assigned to this intervention follow three cycles of a five-day reduced-calorie diet, with one cycle administered each month and regular diet during the rest of the month.
- Regular Diet: Participants assigned to the control arm follow their regular diet. The registry does not provide further instructions for this diet.
Study design
How the comparison works
This is a randomized, parallel-group interventional study comparing a fasting-mimicking diet with a regular-diet control. The registry estimates enrollment of 75 participants. Participants are randomly assigned to one of the two parallel study groups, but the assignment ratio is not reported. The study is unblinded, meaning the registry reports no masking. The control group is assigned to a regular diet; the registry provides no additional description of that diet. The registry codes the regular-diet arm as a placebo comparator, but it does not describe a separate placebo or sham intervention.
Reported activities
Procedures and tests
- Partial Mayo score assessments covering stool frequency, rectal bleeding, and physician global assessment without endoscopy.
- Modified Mayo score assessments covering stool frequency, rectal bleeding, and an endoscopy subscore.
- A yes-or-no patient global assessment asking whether the participant believes their ulcerative colitis symptoms are in remission.
- Measurement of C-reactive protein and erythrocyte sedimentation rate when elevated at baseline.
- Measurement of fecal calprotectin when elevated at baseline.
- Assessment of endoscopic outcomes using the modified Mayo endoscopic subscore.
- Patient-reported symptom assessment using the PRO2 stool-frequency and rectal-bleeding measures.
- Quality-of-life assessment using the Short Inflammatory Bowel Disease Questionnaire.
- Cytokine, chemokine, and immune-cell profiling using flow cytometry and mass cytometry.
- Analysis of gut metabolites and microbiome profiles using 16S ribosomal RNA and shotgun metagenomics methods.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Ulcerative colitis must be mild to moderate, with a partial Mayo score from 2 through 7 out of 9.
- Participants must be ages 18 through 70 at the start of the study, inclusive.
Possible reasons someone may not be able to join
- People who are pregnant, nursing, or expect to become pregnant are excluded.
- People with a nut allergy are excluded.
- People with a body mass index below 18 are excluded.
- A serious medical condition may exclude someone unless a physician provides written approval.
- People taking medication that may not be safe with a calorie-restricted diet are excluded.
- People with diabetes who use anti-diabetic drugs associated with hypoglycemia risk are excluded.
- More than mild-to-moderate cardiovascular disease or life-threatening cancer may exclude someone unless a physician approves.
- A history of severe cardiac disease is excluded, particularly uncompensated congestive heart failure of New York Heart Association grade 2 or higher or left ventricular ejection fraction below 40%.
- Dietary needs that are incompatible with the fasting-mimicking diet meal plan are exclusionary.
- Liver or kidney disorders that may be affected by the diet's very low glucose and protein content are exclusionary.
- People already following a calorie-restricted diet are excluded.
- Relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, an intestinal ostomy, colectomy, proctocolectomy, or an ileoanal pouch are exclusionary.
Important unknowns
What the record does not make clear
- The record gives assessment windows but does not state the number, format, or length of study visits.
- The record describes three monthly diet cycles and a later assessment but does not clearly state each participant's total period of involvement.
- The study is randomized, but the assignment ratio is not reported. The regular-diet arm is coded as a placebo comparator even though no separate placebo or sham is described.
- The record does not identify which ulcerative colitis treatments may continue during the study.
- The eligibility criteria exclude medications considered unsafe with calorie restriction but do not state whether any medications require a washout period.
- The record does not explain how worsening ulcerative colitis symptoms would be managed during the study.
- Endoscopic outcomes and an endoscopy subscore are listed, but the record does not state whether the study requires a new endoscopy or may use an existing examination.
- The record does not state which study-related care, diet materials, tests, or procedures are paid for or billed to insurance.
- The record does not report whether participants receive payment or reimbursement.
- The record does not report parking, transportation, lodging, or other travel support.
- The record lists a Stanford location but does not say whether any visits or assessments can be completed remotely.
- The Stanford site is listed as recruiting, but the record does not confirm current openings for a particular participant or study arm.
Before contacting the site
Questions for the study team
- How many visits are required, which are in person, and what happens at each visit?
- What is the chance of assignment to each diet group?
- What foods, calorie amounts, and support are included in each five-day fasting-mimicking diet cycle?
- Which current ulcerative colitis medicines may continue, and are any medication changes or washout periods required?
- Is a new colonoscopy or sigmoidoscopy required for the endoscopic outcome assessments?
- What happens if ulcerative colitis symptoms worsen during a diet cycle or follow-up?
- Which study-related food, tests, procedures, parking, or travel costs are covered?
- Is the Stanford site currently screening, and can any study activities be completed remotely?
Before changing care
Questions for your gastroenterologist
- Could a five-day reduced-calorie diet be medically appropriate given my current disease activity, nutritional status, and other conditions?
- Would any of my ulcerative colitis medicines or other prescriptions conflict with the fasting-mimicking diet?
- How stable should my ulcerative colitis be before I consider contacting the research team?
- What approved treatment and nutrition alternatives should I understand before considering this research study?
- How should my usual gastroenterology care be coordinated with the research team if I contact the study?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Stanford University
- Organization class
- Other
- Organization study ID
- IRB 47075
- Lead sponsor
- Stanford University
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Fasting Mimicking Diet
Three cycles of a 5-day reduced calorie diet
Interventions: Other: Fasting Mimicking Diet
Placebo Comparator
Regular Diet Control Arm
Interventions: Other: Regular Diet
Interventions
Other
Fasting Mimicking Diet
5 day reduced calorie diet
Other
Regular Diet
Regular Diet
Eligibility
18 Years–70 Years
All
Not accepted
Inclusion criteria (2)
- Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7)Registry-derived · unreviewed
- Age of 18-70 at start of study (inclusive)Registry-derived · unreviewed
Exclusion criteria (14)
- Women who are pregnant or nursing or expect to be pregnantRegistry-derived · unreviewed
- Individuals allergic to nutsRegistry-derived · unreviewed
- Individuals with a body mass index (BMI) lower than 18Registry-derived · unreviewed
- Individuals diagnosed with a serious medical condition as defined by the patient's physician, unless approved in writing by a physicianRegistry-derived · unreviewed
- Individuals who have been severely weakened by a disease or medical procedure,Registry-derived · unreviewed
- Individuals who are taking medication which may not be safely consumed with a calorie restricted dietRegistry-derived · unreviewed
- Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemiaRegistry-derived · unreviewed
- Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physicianRegistry-derived · unreviewed
- Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)Registry-derived · unreviewed
- Individuals with a history of syncopeRegistry-derived · unreviewed
- Individuals with dietary needs incompatible with the FMD meal planRegistry-derived · unreviewed
- Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet.Registry-derived · unreviewed
- Patients on a caloric restricted diet will also be excluded.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Clinical response as per partial Mayo score
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.
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
Clinical remission as per partial Mayo score
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.
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.
Secondary outcome
Clinical remission as per modified Mayo (mMayo) score
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.
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.
Secondary outcome
Clinical response as per mMayo score
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.
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.
Secondary outcome
Patient global assessment
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.
"Do you believe you are in remission from your UC symptoms?" (Yes/No). No scale.
Secondary outcome
Change in C-Reactive Protein (CRP).
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.
Change in the inflammatory marker CRP (if elevated at baseline).
Secondary outcome
Change in Erythrocyte Sedimentation Rate (ESR).
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.
Change of the inflammatory marker ESR (if elevated at baseline).
Secondary outcome
Change in Fecal Calprotectin.
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.
Change of the inflammatory marker fecal calprotectin (if elevated at baseline).
Secondary outcome
Effect of FMD on endoscopic outcomes
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.
Changes in modified Mayo (mMayo) endoscopic subscore. The subscore ranges from 0 to 3 points with higher scores reflecting more severe disease.
Secondary outcome
Symptomatic remission as per Patient Reported Outcome (PRO2) score
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.
Defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0.
Secondary outcome
Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score
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.
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).
Recruiting locations in the United States
Stanford University
RecruitingPalo Alto, California, 94305, United States
Touran Fardeentfardeen@stanford.edu
Central study contacts
Registry dates
- First posted
- Aug 6, 2018
- Primary completion
- Dec 2027
- Overall completion
- Dec 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.