The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

NCT03615690 | Recruiting

• 1 other identifier: IRB 47075
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease; Diet Modification; Ulcerative Colitis

Keywords

ulcerative colitis; IBD; diet; fasting; fasting mimicking diet; UC; intermittent fasting

Outcome Measures

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.

  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

  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

  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

  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

  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).

  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.

Other Outcomes (4)

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

  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.

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

  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.

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

  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.

Study Arms (2)

Fasting Mimicking Diet

EXPERIMENTAL

Three cycles of a 5-day reduced calorie diet

Other: Fasting Mimicking Diet

Regular Diet Control Arm

PLACEBO COMPARATOR

Other: Regular Diet

Interventions

Fasting Mimicking Diet OTHER

5 day reduced calorie diet

Fasting Mimicking Diet

Regular Diet OTHER

Regular Diet

Regular Diet Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Fasting; Intermittent Fasting

Interventions

Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sidhartha R Sinha, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Touran Fardeen

CONTACT

6507367311; tfardeen@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 6, 2018
• Study Start: December 15, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)