Inflammatory Bowel DiseasesNCT06342011
Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease
A study testing Anti-inflammatory diet group in people with Inflammatory Bowel Diseases, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Anti-inflammatory diet group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of inflammatory bowel disease, the diagnostic criteria refer to the 2018 revised Consensus opinion on the diagnosis and treatment of inflammatory bowel disease;
- The patient has clear consciousness and certain understanding, language expression and writing ability;
- Patients participated in this study knowingly and voluntarily;
- At least 18 years old.
Who cannot join
- cognitive impairment, mental illness, accompanied by mental disorders;
- Alcohol and drug abusers.
- The patient could not participate in the researcher due to the deterioration of the condition;
- Patients who voluntarily quit due to other reasons;
- Those who did not complete the assessment scale during the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Xia Qian, BA, 15968110117, 1632936247@qq.com
About this study
Official title: Effects of Anti-inflammatory Diet on Inflammatory Markers, Anxiety, Depression and Quality of Life in Patients With Inflammatory Bowel Disease
For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients.
Read the detailed description
This study aims to verify the intervention effect of AID on IBD patients, promote the promotion of AID model, and provide new ideas for the prevention and treatment strategies of IBD patients.
In this study, 66 IBD patients who met the inclusion criteria were divided into experimental group and control group by randomized controlled trial method. The experimental group was based on routine nursing measures, and the intervention group taught patients to take anti-inflammatory diet and use the anti-inflammatory diet mini-program developed by the researcher, daily anti-inflammatory diet, intervention time was 8 weeks, and observed the inflammatory indicators (white blood cells, neutrophils, erythrocyte precipitation, CRP), quality of life, anxiety and depression, self-efficacy and other conditions in the blood results of the patients before and after intervention.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Anti-inflammatory diet group
- Keywords
- Anti-inflammatory diet, Inflammatory index, Quality of life
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory diet groupBehavioural
Patients in the intervention group were given AID knowledge education, and patients were asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by the researchers to teach patients how to use it, including the selection of anti-inflammatory diet, unsuitable anti-inflammatory diet, diet alarm clock, diet notes and other related functions. The missionary patients insisted on AID until reexamination 8 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Regular diet group | No intervention | Explain disease related knowledge; According to the patient's situation, give personalized dietary guidance, establish regular eating habits, carefully evaluate the types of food in the food, and avoid spicy stimulation, gas production, high fat and other foods that are easy to cause intestinal discomfort. SMS follow-up was conducted 3 days after discharge, and weekly phone follow-up was conducted to see if patients needed to solve problems and help them solve them in time. |
| Anti-inflammatory diet group | Experimental | AID knowledge education was given to patients in the intervention group after admission. At the same time, patients are asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by researchers, and teach patients how to use it, including the choice of anti-inflammatory diet, inappropriate anti-inflammatory diet, diet alarm clock, diet notes and other related functions. Missionary patients persisted with AID until re-examination 8 weeks later.
The researchers conducted weekly telephone follow-up to urge the patients to adhere to the AID diet, answer the questions raised by the patients during the implementation process, and understand the patients' knowledge acceptance and diet implementation. Follow-up is carried out by qualified members of the training research team. Follow-up can take the form of face-to-face visit to the community or direct telephone follow-up, and make follow-up records. Receives: Behavioral: Anti-inflammatory diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
C-reactive protein (mg/L) is a non-specific inflammatory marker. It is an acute phase reaction protein synthesized by the liver to protect the body when pathogenic microorganisms invade the body.
Measured: 8 weeks after intervention
Erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (mm/h) refers to the rate of erythrocyte sedimentation under certain conditions. The anticoagulant blood is placed in a vertically erected small glass tube. Due to the large proportion of red blood cells, it is naturally sunk by gravity. Under normal circumstances, the subsidence is very slow. The rate of erythrocyte sedimentation is often expressed by the distance of red blood cells sinking at the end of the first hour, called ESR.
Measured: 8 weeks after intervention
Leukocyte
White blood cells are colorless, spherical, nucleated blood cells. The total number of normal adults is (4.0 ~ 10.0)x 109/L, which can change in a certain range depending on the time of day and the functional state of the body.
Measured: 8 weeks after intervention
Secondary outcomes (5)
Self-Rating Anxiety Scale，SAS
This table, compiled by Zung in 1971, is used in SAS for a total of 20 symptom categories, with a score of 1 to 4 after each problem. The scoring scale is: "1" indicates that the symptom is rarely present; A score of "2" indicates that this symptom is sometimes present; A score of "3" indicates that the symptoms are present most of the time; A score of "4" indicates symptoms most of the time. The cut-off value of SAS standard score is 50 points, of which < 50 is no anxiety, 50 to 59 is mild anxiety, 60 to 69 is moderate anxiety, and more than 70 is severe anxiety.
Measured: 8 weeks after intervention
Self-Rating depression scale，SDS
The scale is scored on the following scale: "1" means that this symptom rarely occurs; A score of "2" indicates that this symptom sometimes occurs; A score of "3" means the symptoms are present most of the time; A score of "4" means that symptoms occur in most cases. Among them, 10 items are positive (1, 2, 3, 4 points in sequence), and 2, 5, 6, 11, 12, 14, 16, 17, 18, 20 items are negative (4, 3, 2, 1 points in sequence). The total score is obtained by adding all the scores together. Multiply the total score by 1.25, and the points portion is obtained from the SDS standard score. SDS standard score 53 points, mild depression 53 to 62 points, moderate depression 63 to 72 points. Major depressive disorder is... Seventy-two o 'clock.
Measured: 8 weeks after intervention
Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ)
In this study, the simplified Chinese version of inflammatory bowel Disease Quality of Life Scale was used to assess the quality of life of IBD patients. This scale is the most widely used inflammatory bowel disease specific quality of life scale in the world, with a Cronbach's of 0.986, indicating good reliability and validity. The scale consists of 32 items and 4 dimensions, and mainly evaluates the intestinal symptoms, systemic symptoms, emotional ability and social ability of IBD patients. Each entry has seven options on a scale of 1-7, with 1 representing the worst and 7 representing the best, on a scale of 32-224, with higher scores indicating better quality of life.
Measured: 8 weeks after intervention
Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)
In this study, the Chinese version of the inflammatory bowel disease Self-efficacy Scale (GSES) was used for assessment. The GSES has 29 items and 4 dimensions, including stress and emotion management, medical care management, disease management and remission maintenance management. Cronbach's coefficient ranges from 0.899 to 0.973, and Guttman's half coefficient ranges from 0.825 to 0.917. Score using the Likert 10-level scoring method, with a total score of 29-290, the higher the score, the stronger the sense of self-efficacy.
Measured: 8 weeks after intervention
Body Mass Index
The patient's weight gain was measured first，weight in kilograms, height in meters,weight and height will be combined to report BMI in kg/m^2.
Measured: 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia Qian, BA, Principal investigator, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342011
- Sponsor's protocol ID
- KY-2024-039
- Status last verified
- Feb 2025
- First submitted
- 10 Mar 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-inflammatory Diet on Inflammatory Markers, Anxiety, Depression and Quality of Life in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06342011
- Acronym / sponsor ID
- KY-2024-039
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Anti-inflammatory diet, Inflammatory index, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2024 (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.
For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients.
Detailed description
This study aims to verify the intervention effect of AID on IBD patients, promote the promotion of AID model, and provide new ideas for the prevention and treatment strategies of IBD patients.
In this study, 66 IBD patients who met the inclusion criteria were divided into experimental group and control group by randomized controlled trial method. The experimental group was based on routine nursing measures, and the intervention group taught patients to take anti-inflammatory diet and use the anti-inflammatory diet mini-program developed by the researcher, daily anti-inflammatory diet, intervention time was 8 weeks, and observed the inflammatory indicators (white blood cells, neutrophils, erythrocyte precipitation, CRP), quality of life, anxiety and depression, self-efficacy and other conditions in the blood results of the patients before and after intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular diet group | No intervention | –Explain disease related knowledge; According to the patient's situation, give personalized dietary guidance, establish regular eating habits, carefully evaluate the types of food in the food, and avoid spicy stimulation, gas production, high fat and other foods that are easy to cause intestinal discomfort. SMS follow-up was conducted 3 days after discharge, and weekly phone follow-up was conducted to see if patients needed to solve problems and help them solve them in time. |
| Anti-inflammatory diet group | Experimental | Behavioral: Anti-inflammatory diet groupAID knowledge education was given to patients in the intervention group after admission. At the same time, patients are asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by researchers, and teach patients how to use it, including the choice of anti-inflammatory diet, inappropriate anti-inflammatory diet, diet alarm clock, diet notes and other related functions. Missionary patients persisted with AID until re-examination 8 weeks later. The researchers conducted weekly telephone follow-up to urge the patients to adhere to the AID diet, answer the questions raised by the patients during the implementation process, and understand the patients' knowledge acceptance and diet implementation. Follow-up is carried out by qualified members of the training research team. Follow-up can take the form of face-to-face visit to the community or direct telephone follow-up, and make follow-up records. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of inflammatory bowel disease, the diagnostic criteria refer to the 2018 revised Consensus opinion on the diagnosis and treatment of inflammatory bowel disease;
- The patient has clear consciousness and certain understanding, language expression and writing ability;
- Patients participated in this study knowingly and voluntarily;
- At least 18 years old.
Key exclusion criteria (5 listed)
- cognitive impairment, mental illness, accompanied by mental disorders;
- Alcohol and drug abusers.
- The patient could not participate in the researcher due to the deterioration of the condition;
- Patients who voluntarily quit due to other reasons;
- Those who did not complete the assessment scale during the experiment.
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 |
|---|---|---|
| Anti-inflammatory diet groupPatients in the intervention group were given AID knowledge education, and patients were asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by the researchers to teach patients how to use it, including the selection of anti-inflammatory diet, unsuitable anti-inflammatory diet, diet alarm clock, diet notes and other related functions. The missionary patients insisted on AID until reexamination 8 weeks later. | Behavioural | Anti-inflammatory diet group |
Primary outcome
C-reactive protein
Time frame: 8 weeks after intervention
C-reactive protein (mg/L) is a non-specific inflammatory marker. It is an acute phase reaction protein synthesized by the liver to protect the body when pathogenic microorganisms invade the body.
Erythrocyte sedimentation rate (ESR)
Time frame: 8 weeks after intervention
Erythrocyte sedimentation rate (mm/h) refers to the rate of erythrocyte sedimentation under certain conditions. The anticoagulant blood is placed in a vertically erected small glass tube. Due to the large proportion of red blood cells, it is naturally sunk by gravity. Under normal circumstances, the subsidence is very slow. The rate of erythrocyte sedimentation is often expressed by the distance of red blood cells sinking at the end of the first hour, called ESR.
Leukocyte
Time frame: 8 weeks after intervention
White blood cells are colorless, spherical, nucleated blood cells. The total number of normal adults is (4.0 ~ 10.0)x 109/L, which can change in a certain range depending on the time of day and the functional state of the body.
5 secondary outcomes
Self-Rating Anxiety Scale，SAS
Time frame: 8 weeks after intervention
Self-Rating depression scale，SDS
Time frame: 8 weeks after intervention
Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ)
Time frame: 8 weeks after intervention
Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)
Time frame: 8 weeks after intervention
Body Mass Index
Time frame: 8 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Xia Qian, BA principal investigator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory diet group in people with Inflammatory Bowel Diseases, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Qian, BA (15968110117, 1632936247@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (time frame: 8 weeks after intervention). The study lists 3 primary outcomes in all. 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 17 Feb 2025.