RECRUITING

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Conditions

Inflammatory Bowel Disease Diet Modification Ulcerative Colitis IBD diet fasting fasting mimicking diet UC intermittent fasting

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Quick Facts

Study Start:2020-12-15

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03615690

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Touran Fardeen

CONTACT

6507367311

tfardeen@stanford.edu

Principal Investigator

Sidhartha R Sinha, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Palo Alto, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Sidhartha R Sinha, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-15

Study Completion Date2025-12

Study Record Updates

Study Start Date2020-12-15

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

ulcerative colitis
IBD
diet
fasting
fasting mimicking diet
UC
intermittent fasting

Additional Relevant MeSH Terms

Inflammatory Bowel Disease
Diet Modification
Ulcerative Colitis