The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fasting Mimicking Diet
Other intervention5 day reduced calorie diet
Regular Diet
Other interventionRegular Diet
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Fasting Mimicking DietExperimental treatment 1 intervention
Group B: Regular Diet Control ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 outcomes
1
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.
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.2
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.
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.3
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.
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.4
Patient global assessment
"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.Other outcomes
1
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.
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.2
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, 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.3
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).
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.4
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov