Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Crohn Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: Single (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.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 studie...

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.

Tracking Information

NCT #
NCT04736368
Collaborators
Not Provided
Investigators
Not Provided