Crohn DiseaseNCT04736368
Effect of EDIP Based Diet on CD Activity
A study testing EDIP Diet Suggestions and diet guidance in people with Crohn Disease, run by First Affiliated Hospital of Zhejiang University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- EDIP Diet Suggestions and diet guidance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a confirmed diagnosis of CD were actively included for different treatment strategies.
Who cannot join
- Participants with multi-system organ failure and/or other severe diseases not suitable for CD treatment intervention were further excluded.
About this study
Official title: Empirical Dietary Inflammatory Pattern (EDIP) Based Dietary Suggestion on Disease Activity and Cerebrovascular Function in Crohn's Disease
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- EDIP Diet Suggestions, diet guidance
- Keywords
- Crohn's Disease, EDIP diet, Therapy, Cerebrovascular Function
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDIP Diet SuggestionsOther
CD participants will receive EDIP diet suggestions after random allocation.
diet guidanceOther
Control group will be given diet guidance according to routine experience under the participant's request.
| Study group | Role | What they receive |
|---|---|---|
| EDIP Group | Experimental | CD participants will receive EDIP diet information Receives: Other: EDIP Diet Suggestions |
| Control Group | Placebo comparator | CD participants will be given diet suggestions according to routine experience. Receives: Other: diet guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chron's Disease Activity Index
The participants disease activity will be assessed with CDAI index.
Measured: 14 weeks post enrollment.
Secondary outcomes (2)
Mucosal Changes
The status and degree of mucosal healing will be assessed by colonoscopy.
Measured: 14 weeks post enrollment.
Cerebrovascular Function
Near infrared spectroscopy will be used to assess cerebrovascular function.
Measured: 14 weeks post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start26 Jan 2021 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736368
- Sponsor's protocol ID
- EDIPstudy
- Status last verified
- Jan 2021
- First submitted
- 31 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Dietary Inflammatory Pattern (EDIP) Based Dietary Suggestion on Disease Activity and Cerebrovascular Function in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04736368
- Acronym / sponsor ID
- EDIPstudy
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, EDIP diet, Therapy, Cerebrovascular Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 26 Jan 2021 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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 .
| Arm | Type | Receives |
|---|---|---|
| EDIP Group | Experimental | Other: EDIP Diet SuggestionsCD participants will receive EDIP diet information |
| Control Group | Placebo comparator | Other: diet guidanceCD participants will be given diet suggestions according to routine experience. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with a confirmed diagnosis of CD were actively included for different treatment strategies.
Key exclusion criteria (1 listed)
- Participants with multi-system organ failure and/or other severe diseases not suitable for CD treatment intervention were further excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDIP Diet SuggestionsCD participants will receive EDIP diet suggestions after random allocation. | Other | EDIP Group |
| diet guidanceControl group will be given diet guidance according to routine experience under the participant's request. | Other | Control Group |
Primary outcome
Chron's Disease Activity Index
Time frame: 14 weeks post enrollment.
The participants disease activity will be assessed with CDAI index.
2 secondary outcomes
Mucosal Changes
Time frame: 14 weeks post enrollment.
Cerebrovascular Function
Time frame: 14 weeks post enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EDIP Diet Suggestions and diet guidance in people with Crohn Disease, run by First Affiliated Hospital of Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chron's Disease Activity Index (time frame: 14 weeks post enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.