Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04736368 |
| Other study ID # |
EDIPstudy |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2021 |
| Est. completion date |
July 31, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
First Affiliated Hospital of Zhejiang University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
