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Search / Trial NCT03615690

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Launched by STANFORD UNIVERSITY · Jul 30, 2018

Trial Information

Current as of May 08, 2025

Recruiting

Keywords

Ulcerative Colitis Ibd Diet Fasting Fasting Mimicking Diet Uc Intermittent Fasting

ClinConnect Summary

This clinical trial is studying how a special diet, called a fasting mimicking diet (FMD), can help reduce inflammation in people with mild to moderate Ulcerative Colitis (UC), a type of inflammatory bowel disease. The FMD allows participants to experience some of the benefits of fasting while still enjoying food that is safe and approved by health authorities. Researchers want to see if this diet can lower inflammation levels and improve the overall quality of life for those with UC after three cycles of following the diet for five days at a time.

To participate in this study, you need to be between 18 and 70 years old and have mild to moderate UC, which can be measured with a specific scoring system. However, certain individuals, such as pregnant women, people with severe medical conditions, or those who have specific dietary restrictions, may not be eligible. If you join the trial, you'll follow the FMD for the specified periods and be monitored by healthcare professionals to track your health and any changes in your symptoms. This research is important because there is limited information on how dietary changes can impact UC, and it may open new options for treatment in the future.

Gender

ALL

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.

About Stanford University

Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.

Locations

Palo Alto, California, United States

Patients applied

0 patients applied

Trial Officials

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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