ClinicalTrials.gov

History of Changes for Study: NCT03615690
The Influence of Fasting and Diet on Intestinal Inflammation
Latest version (submitted April 21, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 July 30, 2018 None (earliest Version on record)
2 January 29, 2019 Study Status
3 May 7, 2019 Study Status, Outcome Measures, Study Design, Contacts/Locations and Arms and Interventions
4 July 30, 2019 Study Status and Outcome Measures
5 October 29, 2019 Outcome Measures, Study Status, Arms and Interventions, Study Design, Conditions, Study Identification, Eligibility, Study Description and Oversight
6 January 26, 2020 Outcome Measures, Study Status, Eligibility and Arms and Interventions
7 April 17, 2020 Outcome Measures, Study Status and Eligibility
8 February 17, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
9 April 30, 2021 Contacts/Locations, Study Status and Sponsor/Collaborators
10 April 21, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03615690
Submitted Date:  July 30, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB 47075
Brief Title: The Influence of Fasting and Diet on Intestinal Inflammation
Official Title: The Influence of Fasting and Diet on Intestinal Inflammation
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2018
Overall Status: Not yet recruiting
Study Start: September 2018
Primary Completion: December 2019 [Anticipated]
Study Completion: September 2020 [Anticipated]
First Submitted: July 3, 2018
First Submitted that
Met QC Criteria:
July 30, 2018
First Posted: August 6, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
July 30, 2018
Last Update Posted: August 6, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Stanford University
Responsible Party: Principal Investigator
Investigator: Sidhartha R Sinha
Official Title: Assistant Professor of Medicine
Affiliation: Stanford University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 Inflammatory Bowel Disease (IBD). 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 IBD 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 a five-day period of the fasting mimicking diet, after either one five-day cycle or three five-day cycles, and may provide rationale for its use to treat IBD.
Detailed Description:
Open or close this module Conditions
Conditions: Inflammatory Bowel Diseases
Diet Modification
Ulcerative Colitis
Crohn's Disease
Keywords: ulcerative colitis
IBD
diet
fasting
fasting mimicking diet
crohns
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Single group assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Fasting Mimicking Diet
Either one cycle of 5 day of reduced calorie diet over one month, or optional three cycles of reduced calorie diet over three months.
Fasting mimicking diet
5 day reduced calorie diet, commercially available
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in Fecal Calprotectin
[ Time Frame: Comparison of calprotectin levels 1-3 days before Cycle 1, within 48 hours after Cycle 1 and three months after Cycle 3. ]

P value of .05 or less will be considered statistically significant
2. Change in C-Reactive Protein(CRP)
[ Time Frame: Comparison of CRP 1-3 days before Cycle 1, within 48 hours after Cycle 1, 1-3 days before Cycle 2, within 48 hours after Cycle 3, 1 month after Cycle 3, and 3 months after Cycle 3 ]

P value of .05 or less will be considered statistically significant
3. Change in Erythrocyte Sedimentation Rate(ESR)
[ Time Frame: Comparison of ESR 1-3 days before Cycle 1, within 48 hours after Cycle 1, 1-3 days before Cycle 2, within 48 hours after Cycle 3, 1 month after Cycle 3, and 3 months after Cycle 3 ]

P value of .05 or less will be considered statistically significant
4. Change in disease score(either Non-endoscopic Modified Mayo Score or CDAI)
[ Time Frame: Comparison of disease score 1-3 days before Cycle 1, 5 days after Cycle 1, 5 days after Cycle 3 and 3 months after Cycle 3 ]

Change in at least 2 points on the Mayo score/100 points on CDAI will define clinical success
5. Change in SIBDQ Score
[ Time Frame: Comparison of SIBDQ score 1-3 days before Cycle 1, 5 days after Cycle 1, 5 days after Cycle 3 and 3 months after Cycle 3 ]

Quality of life score in IBD patients
Secondary Outcome Measures:
1. Change in Inflammatory cytokines and chemokines
[ Time Frame: Comparison of cytokines/chemokines 1-3 days before Cycle 1, within 48 hours after Cycle 1, 1-3 days before Cycle 2, within 48 hours after Cycle 3, 1 month after Cycle 3, and 3 months after Cycle 3 ]

TNF-a, IL-17, etc.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Mild to moderate ulcerative colitis on the Modified Mayo Score out of 9 (score between 2 to 6)
  • Mild to moderate Crohn's disease (CDAI score between 150-450)
  • Age of 18-70 at start of study
  • Elevated stool calprotectin and/or serum inflammatory marker levels (ESR and/or CRP).

Exclusion Criteria:

  • Children under the age of 18
  • Women who are pregnant or nursing
  • 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, cardiovascular disease and cancer unless approved in writing by a licensed physician
  • individuals on glucose lowering drugs
  • individuals with history of significant 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 ProLon 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.
Open or close this module Contacts/Locations
Central Contact Person: Cuiping Li
Telephone: 6507367311
Email: cl44@stanford.edu
Study Officials: Sidhartha R Sinha, MD
Principal Investigator
Stanford University
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services