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NCT Number: NCT07656805

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location status: Recruiting

Location contact

Huimin Guo

CONTACT

[email protected]

+8615399593640

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Standard Diabetes Dietary Advice

Behavioral

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

Primary outcomes

  1. high-sensitivity C-reactive protein (hs-CRP)

    Time frame: Week 4

Secondary outcomes

  1. Fasting Blood Glucose (FBG)

    Time frame: Week 4

  2. 2-hour Postprandial Blood Glucose (2hPBG)

    Time frame: Week 4

  3. Dietary Inflammatory Index (DII)

    Time frame: Week 4

  4. Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus

    Time frame: Week 4

  5. Diabetes-specific quality of life scale score

    Time frame: Week 4

Study contacts

Contact information is provided by the study sponsor or research team.

Huimin Guo

CONTACT

[email protected]

+8615399593640

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study title

Evidence-based Construction and Application of an Anti-inflammatory Diet Intervention for Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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