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The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a diet that aims to give the effects of fasting while still allowing food. It is for adults ages 18–70 with mild to moderate ulcerative colitis (UC), a disease that causes swelling in the large intestine. Researchers will check whether three 5-day diet cycles reduce swelling or improve quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–70 when the study starts.
  • Mild to moderate UC, with a score of 2–7 on the partial Mayo scale, which measures UC symptoms.

Who can't join

  • Pregnant, nursing, or expecting to become pregnant.
  • Allergic to nuts, or having food needs that do not fit the study meal plan.
  • Body mass index (BMI), a measure of weight compared with height, below 18; or already on a diet that limits calories.
  • A serious medical condition, unless a doctor gives written approval; or being severely weakened by a disease or medical procedure.
  • Taking medicines that are unsafe with a low-calorie diet, including diabetes drugs that may cause low blood sugar.
  • More than mild to moderate heart or blood vessel disease, or life-threatening cancer, unless a doctor approves. A history of severe heart disease or fainting also rules you out.
  • Liver or kidney problems that may be affected by the diet’s very low sugar and protein levels.
  • Past digestive tract surgery with effects such as a shortened bowel, a bowel opening through the belly, removal of part or all of the colon or rectum, or an internal pouch made from the small intestine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA