Effect of EDIP Based Diet on CD Activity
Primary Purpose
Crohn Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EDIP Diet Suggestions
diet guidance
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, EDIP diet, Therapy, Cerebrovascular Function
Eligibility Criteria
Inclusion Criteria:
- Participants with a confirmed diagnosis of CD were actively included for different treatment strategies.
Exclusion Criteria:
- Participants with multi-system organ failure and/or other severe diseases not suitable for CD treatment intervention were further excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EDIP Group
Control Group
Arm Description
CD participants will receive EDIP diet information
CD participants will be given diet suggestions according to routine experience.
Outcomes
Primary Outcome Measures
Chron's Disease Activity Index
The participants disease activity will be assessed with CDAI index.
Secondary Outcome Measures
Mucosal Changes
The status and degree of mucosal healing will be assessed by colonoscopy.
Cerebrovascular Function
Near infrared spectroscopy will be used to assess cerebrovascular function.
Full Information
NCT ID
NCT04736368
First Posted
January 31, 2021
Last Updated
February 2, 2021
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04736368
Brief Title
Effect of EDIP Based Diet on CD Activity
Official Title
Empirical Dietary Inflammatory Pattern (EDIP) Based Dietary Suggestion on Disease Activity and Cerebrovascular Function in Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2021 (Anticipated)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Crohn's disease is a chronic recurrent systemic inflammatory disease. Studies have shown that meat, dairy products, fiber and vitamin D may affect the risk of Crohn's disease. The relationship between other dietary components and disease activity or recurrence in Chron's disease has not been fully studied. Although the patient's diet will affect the degree of disease activity, there is still no recognized daily diet model for CD patients. At present, the change of intestinal microbiome is considered to be one of the causes of IBD, and this change provides a theoretical basis for diet to reduce the inflammatory response in CD patients through the regulation of microbiome. Food driven inflammation may affect the activity of the disease. Brain-gut axis interaction may play an important role in CD and may have an effect on the cerebrovascular system. The investigators aim to evaluate the effects of Empirical Dietary Inflammatory Pattern (EDIP) based dietary suggestions on disease activity and cerebrovascular function as well as changes of intestinal flora and its metabolites amongst Chron's disease participants of all ages.
Detailed Description
Crohn's disease (CD) is a chronic recurrent systemic inflammatory disease, mainly affecting the gastrointestinal tract, accompanied by extra-intestinal complications and immune dysfunction. The relationship between other dietary components and disease activity or recurrence has not been fully studied and there is still no recognized daily diet model for CD. At present, the change of intestinal microbiome is considered to be one of the causes of Irritable Bowel Disease (IBD), and this change provides a theoretical basis for diet to reduce the inflammatory response those with CD through the regulation of microbiome. In inflammatory diseases, the potential inflammation of food may affect the activity of the disease. Empirical Dietary Inflammatory Pattern (EDIP) is a dietary inflammation index based on food group. 18 food groups were selected to evaluate the levels of inflammatory factors in human body which have already been verified by two independent female and male cohorts. The construction and validation of the scoring model revealed a strong correlation between EDIP and three plasma inflammatory markers: IL-6, CRP and TNFaR2, as well as other markers, such as adiponectin and the overall inflammatory marker score. Therefore, EDIP can be derived in a standardized way in different populations and be used to examine association with diseases whose pathogenesis is mainly attributed to chronic inflammation. Dietary inflammation index (DII) is a previously developed inflammation index based on nutrients. Compared to DII, dietary patterns based on food groups, such as EDIP, are more valuable for the establishment of dietary guidelines for health promotion and disease prevention. In addition, the brain-gut axis is the kink between the central nervous system and intestinal function but has not been extensively studied. In view of the fact that autoimmune diseases, and brain-gut axis interaction may play an important role in CD, we speculate that cerebrovascular function may also change during the occurrence and development of CD, especially during the EDIP score-based diet. The investigators plan to carry out a randomized controlled trial to systematically study the effects of EDIP score-based dietary suggestions on disease activity and cerebrovascular function of CD patients, as well as the changes of intestinal flora and its metabolites. The primary aim of this study is to systematically study the effects of EDIP based dietary recommendations on disease activity and cerebrovascular function of CD patients and establish a diet model suitable for CD patients. The secondary aims are to explore the possible changes of intestinal flora and its metabolites, and evaluate the changes of cerebrovascular function and the possible mechanism of their actions on CD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn's Disease, EDIP diet, Therapy, Cerebrovascular Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design was a single-blinded randomized, parallel assignment clinical trial of CD participants was conducted. Participants were randomized in a 1:1 fashion to either 14-weeks of an EDIP based diet or a normal diet .
Masking
Participant
Masking Description
The study design was a single-blinded randomized, parallel assignment clinical trial of The study design was single blind and the participants did not know what diet intervention is being given to them.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EDIP Group
Arm Type
Experimental
Arm Description
CD participants will receive EDIP diet information
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
CD participants will be given diet suggestions according to routine experience.
Intervention Type
Other
Intervention Name(s)
EDIP Diet Suggestions
Intervention Description
CD participants will receive EDIP diet suggestions after random allocation.
Intervention Type
Other
Intervention Name(s)
diet guidance
Intervention Description
Control group will be given diet guidance according to routine experience under the participant's request.
Primary Outcome Measure Information:
Title
Chron's Disease Activity Index
Description
The participants disease activity will be assessed with CDAI index.
Time Frame
14 weeks post enrollment.
Secondary Outcome Measure Information:
Title
Mucosal Changes
Description
The status and degree of mucosal healing will be assessed by colonoscopy.
Time Frame
14 weeks post enrollment.
Title
Cerebrovascular Function
Description
Near infrared spectroscopy will be used to assess cerebrovascular function.
Time Frame
14 weeks post enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with a confirmed diagnosis of CD were actively included for different treatment strategies.
Exclusion Criteria:
Participants with multi-system organ failure and/or other severe diseases not suitable for CD treatment intervention were further excluded.
12. IPD Sharing Statement
Learn more about this trial
Effect of EDIP Based Diet on CD Activity
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