The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

NCT ID: NCT03615690

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fasting Mimicking Diet

Three cycles of a 5-day reduced calorie diet

Group Type: EXPERIMENTAL

Fasting Mimicking Diet

Intervention Type: OTHER

5 day reduced calorie diet

Regular Diet Control Arm

Group Type: PLACEBO_COMPARATOR

Regular Diet

Intervention Type: OTHER

Regular Diet

Interventions

Fasting Mimicking Diet

5 day reduced calorie diet

Intervention Type: OTHER

Regular Diet

Regular Diet

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sidhartha Ranjit Sinha

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sidhartha R Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Touran Fardeen

Role: CONTACT

tfardeen@stanford.edu

6507367311

Facility Contacts

Touran Fardeen

Role: primary

tfardeen@stanford.edu

Other Identifiers

IRB 47075

Identifier Type: -

Identifier Source: org_study_id