Clinical trial NCT06342011: Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease
Official title: Effects of Anti-inflammatory Diet on Inflammatory Markers, Anxiety, Depression and Quality of Life in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Anti-inflammatory diet
Inflammatory index
Quality of life
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: C-reactive protein
timeFrame: 8 weeks after intervention
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 8 weeks after intervention
measure: Leukocyte
timeFrame: 8 weeks after intervention
Secondary outcomes:
measure: Self-Rating Anxiety Scale，SAS
timeFrame: 8 weeks after intervention
measure: Self-Rating depression scale，SDS
timeFrame: 8 weeks after intervention
measure: Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ)
timeFrame: 8 weeks after intervention
measure: Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)
timeFrame: 8 weeks after intervention
measure: Body Mass Index
timeFrame: 8 weeks after intervention
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: Xia Qian, BA
role: PRINCIPAL_INVESTIGATOR
References: