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Clinical Trials/NCT06342011
NCT06342011
Recruiting
Not Applicable

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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine1 site in 1 country88 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Diseases
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Enrollment
88
Locations
1
Primary Endpoint
Leukocyte
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)(8 weeks after intervention)
  • Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ)(8 weeks after intervention)
  • Body Mass Index(8 weeks after intervention)
  • Self-Rating Anxiety Scale,SAS(8 weeks after intervention)
  • Self-Rating depression scale,SDS(8 weeks after intervention)

Study Sites (1)

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