The goal of this clinical trial is to evaluate whether an evidence-based anti-inflammatory dietary intervention can reduce inflammation and improve glycemic control in patients with type 2 diabetes mellitus (T2DM). T2DM is a chronic metabolic disease characterized by elevated blood glucose levels and is closely associated with chronic low-grade inflammation.
The main questions it aims to answer are:
Does an anti-inflammatory dietary intervention reduce levels of hs-CRP, a key marker of chronic inflammation, in patients with T2DM? Does the intervention improve dietary inflammatory index (DII) scores and glycemic outcomes, including fasting blood glucose and 2-hour postprandial blood glucose? Researchers will compare an anti-inflammatory diet intervention group to a standard diabetes dietary control group to determine whether the anti-inflammatory dietary pattern provides additional benefits beyond routine dietary management.
Participants will:
Be randomly assigned to either the anti-inflammatory diet group or the standard diabetes diet group Receive dietary guidance based on structured anti-inflammatory food recommendations or routine diabetes dietary advice Complete dietary assessments, including 24-hour dietary recalls to calculate dietary inflammatory index (DII) Provide blood samples to measure hs-CRP, fasting blood glucose, and 2-hour postprandial blood glucose at baseline and after 4 weeks Complete questionnaires on dietary adherence and quality of life Participate in a 4-week intervention period with follow-up assessments
Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) according to the Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020 Edition);
Aged 18 years or older;
Able and willing to complete all study questionnaires;
Willing to provide blood samples for laboratory testing;
Patients with a history of diseases affecting blood glucose metabolism, such as hyperthyroidism or Cushing's syndrome;
Pregnant or breastfeeding women;
Patients with severe hepatic dysfunction, renal dysfunction, heart failure, or malignant tumors;
Patients with acute or chronic infectious diseases accompanied by obvious signs of infection, including clinically diagnosed intestinal infections, respiratory tract infections, periodontitis, and other infectious conditions;
Parallel
Anti-inflammatory Dietary Intervention
BehavioralParticipants in this group will receive a 4-week evidence-based anti-inflammatory dietary intervention in addition to routine diabetes care.
Standard Diabetes Dietary Advice
BehavioralParticipants will receive routine dietary guidance for diabetes management according to standard clinical dietary recommendations for 4 weeks.
high-sensitivity C-reactive protein (hs-CRP)
Fasting Blood Glucose (FBG)
2-hour Postprandial Blood Glucose (2hPBG)
Dietary Inflammatory Index (DII)
Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus
Click on the lead sponsor to view all of their trials.
