Anti-inflammatory Dietary Intervention in Patients With Type 2 Diabetes: A Randomized Controlled Trial

NCT07656805 | Recruiting

• 1 other identifier: 81250930
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• high-sensitivity C-reactive protein (hs-CRP)

  Week 4

Secondary Outcomes (5)

• Fasting Blood Glucose (FBG)

  Week 4

• 2-hour Postprandial Blood Glucose (2hPBG)

  Week 4

• Dietary Inflammatory Index (DII)

  Week 4

• Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus

  Week 4

• Diabetes-specific quality of life scale score

  Week 4

Study Arms (2)

Anti-inflammatory Diet Intervention Group

EXPERIMENTAL

Behavioral: Anti-inflammatory Dietary Intervention

Standard Diabetes Diet Control Group

ACTIVE COMPARATOR

Behavioral: Standard Diabetes Dietary Advice

Interventions

Anti-inflammatory Dietary Intervention BEHAVIORAL

Participants in this group will receive a 4-week evidence-based anti-inflammatory dietary intervention in addition to routine diabetes care.

Anti-inflammatory Diet Intervention Group

Standard Diabetes Dietary Advice BEHAVIORAL

Participants will receive routine dietary guidance for diabetes management according to standard clinical dietary recommendations for 4 weeks.

Standard Diabetes Diet Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Possessing adequate communication and comprehension abilities, with no impairment of consciousness, and able to respond to investigators' questions;
• 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:

• 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;
• 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;
• Patients who have undergone gastrointestinal surgery or have diseases that may affect the effectiveness of dietary intervention, such as malabsorption syndrome.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Huimin Guo

CONTACT

+8615399593640; 2445011323@stu.ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

CN (1)