Inflammatory Bowel DiseaseNCT03615690
The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
A study testing Fasting Mimicking Diet and Regular Diet in people with Inflammatory Bowel Disease and Diet Modification, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Disease, Diet Modification, Ulcerative Colitis
- What is being tested?
- Fasting Mimicking Diet and Regular Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Touran Fardeen, tfardeen@stanford.edu
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.
- Being tested
- Fasting Mimicking Diet, Regular Diet
- Keywords
- ulcerative colitis, IBD, diet, fasting, fasting mimicking diet, UC, intermittent fasting
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking DietOther
5 day reduced calorie diet
Regular DietOther
Regular Diet
| Study group | Role | What they receive |
|---|---|---|
| Fasting Mimicking Diet | Experimental | Three cycles of a 5-day reduced calorie diet Receives: Other: Fasting Mimicking Diet |
| Regular Diet Control Arm | Placebo comparator | Not described Receives: Other: Regular Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (10)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Patient global assessment
"Do you believe you are in remission from your UC symptoms?" (Yes/No). No scale.
Measured: 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.
Change in C-Reactive Protein (CRP).
Change in the inflammatory marker CRP (if elevated at baseline).
Measured: 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 Erythrocyte Sedimentation Rate (ESR).
Change of the inflammatory marker ESR (if elevated at baseline).
Measured: 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 in Fecal Calprotectin.
Change of the inflammatory marker fecal calprotectin (if elevated at baseline).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start15 Dec 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidhartha Ranjit Sinha, Stanford University
- Investigators
- Sidhartha R Sinha, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615690
- Sponsor's protocol ID
- IRB 47075
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2018
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03615690
- Acronym / sponsor ID
- IRB 47075
- Keywords
- ulcerative colitis, IBD, diet, fasting, fasting mimicking diet, UC, intermittent fasting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting Mimicking Diet | Experimental | Other: Fasting Mimicking DietThree cycles of a 5-day reduced calorie diet |
| Regular Diet Control Arm | Placebo comparator | Other: Regular Diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting Mimicking Diet5 day reduced calorie diet | Other | Fasting Mimicking Diet |
| Regular DietRegular Diet | Other | Regular Diet Control Arm |
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.
10 secondary outcomes
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.
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.
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.
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.
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 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 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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sidhartha R Sinha, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting Mimicking Diet and Regular Diet in people with Inflammatory Bowel Disease and Diet Modification, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Touran Fardeen (6507367311, tfardeen@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.