Anti-inflammatory Dietary Intervention in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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
Sponsor: Anhui Medical University
You may qualify if…
- ✓ 1. 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);
- ✓ 2. Aged 18 years or older;
- ✓ 3. Able and willing to complete all study questionnaires;
- ✓ 4. Willing to provide blood samples for laboratory testing;
- ✓ 5. Possessing adequate communication and comprehension abilities, with no impairment of consciousness, and able to respond to investigators' questions;
- ✓ 6. Willing to participate in regular follow-up visits and assessments according to the study protocol and able to provide written informed consent.
You may not qualify if…
- ✕ 1. Patients with a history of diseases affecting blood glucose metabolism, such as hyperthyroidism or Cushing's syndrome;
- ✕ 2. Pregnant or breastfeeding women;
- ✕ 3. Patients with severe hepatic dysfunction, renal dysfunction, heart failure, or malignant tumors;
- ✕ 4. 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;
- ✕ 5. A history of recent use of medications that may affect inflammatory or metabolic status, such as nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin) or glucocorticoids;
- ✕ 6. Patients who have undergone gastrointestinal surgery or have diseases that may affect the effectiveness of dietary intervention, such as malabsorption syndrome.
Source: ClinicalTrials.gov · NCT07656805 · last updated 2026-06-18