Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

Effects of Anti-inflammatory Diet on Inflammatory Markers, Anxiety, Depression and Quality of Life in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06342011
• Other study ID #: KY-2024-039
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: Xia Qian, BA
• Phone: 15968110117
• Email: 1632936247[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 31, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of inflammatory bowel disease, the diagnostic criteria refer to the 2018 revised Consensus opinion on the diagnosis and treatment of inflammatory bowel disease;

2. The patient has clear consciousness and certain understanding, language expression and writing ability;

3. Patients participated in this study knowingly and voluntarily;

4. At least 18 years old.

Exclusion Criteria:

1. cognitive impairment, mental illness, accompanied by mental disorders;

2. Alcohol and drug abusers.

3. The patient could not participate in the researcher due to the deterioration of the condition;

4. Patients who voluntarily quit due to other reasons;

5. Those who did not complete the assessment scale during the experiment.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Anti-inflammatory diet group
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.

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Yiwu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks after intervention
Primary	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.	8 weeks after intervention
Primary	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.	8 weeks after intervention
Secondary	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.	8 weeks after intervention
Secondary	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.	8 weeks after intervention
Secondary	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.	8 weeks after intervention
Secondary	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.	8 weeks after intervention
Secondary	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.	8 weeks after intervention