The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03615690
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sidhartha R Sinha, MD
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Bowel Disease, Diet Modification, Ulcerative Colitis
Arms & Interventions

Arms

Experimental: Fasting Mimicking Diet

Three cycles of a 5-day reduced calorie diet

Placebo Comparator: Regular Diet Control Arm

Interventions

Other: - Fasting Mimicking Diet

5 day reduced calorie diet

Other: - Regular Diet

Regular Diet

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Karolin Jarr, MD

jarr@stanford.edu

6507367311

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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