Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03615690

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Inflammatory Bowel Disease Behavior Colitis Colitis, Ulcerative Colonic Diseases Diet Modification Digestive System Diseases Fasting Feeding Behavior Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intermittent Fasting Intestinal Diseases Ulcerative Colitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

Location status: Recruiting

Location contact

Touran Fardeen

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fasting Mimicking diet

Other

5 day reduced calorie diet

Regular Diet

Other

Regular Diet

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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).

Other outcomes

  1. Assessment of primary and key secondary endpoints at baseline versus 3 months after the start of Cycle 3.

    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.

    Outcomes 1 to 11 at additional time points.

  2. Changes in cytokines/chemokines and immune cell profiles using flow cytometry and mass cytometry (CyTOF).

    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.

    Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.

  3. Differences in clinical markers of disease activity at baseline versus within 6 days after completing Cycle 1.

    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.

    Clinical markers of disease activity are CRP, ESR and fecal Calprotectin (if elevated at baseline).

  4. Changes in gut metabolites (including short-chain fatty acid and bile acid profiles) and microbiome profiles (using 16S rRNA/shotgun metagenomics).

    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.

    Gut metabolites include short-chain fatty acid and bile acid profiles.

Study contacts

Contact information is provided by the study sponsor or research team.

Touran Fardeen

CONTACT

[email protected]

6507367311

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2018
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.