Precision nutrition management for prediabetes patients

Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics

This study is testing whether personalized nutrition plans based on genetics can help people with prediabetes manage their blood sugar better than standard diet advice.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06335225 on ClinicalTrials.gov

What this trial studies

This study focuses on developing a precise nutrition management scheme for individuals with prediabetes, utilizing insights from nutrigenomics to tailor nutritional interventions. By analyzing genetic factors that influence nutrient absorption and metabolism, the study aims to provide personalized dietary recommendations. Participants will receive either precise nutritional interventions based on their genetic profiles or conventional nutritional guidance, with the effectiveness and safety of these approaches being evaluated. The goal is to improve glucose metabolism and prevent the progression to diabetes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 who meet specific criteria for prediabetes based on glucose and HbA1c levels.

Not a fit: Patients diagnosed with diabetes or those on medications affecting blood glucose levels will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the management of prediabetes and reduce the risk of developing diabetes.

How similar studies have performed: While the concept of nutrigenomics is emerging, this specific approach to precision nutrition for prediabetes is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. OGTT: 6.1 mmol/L ≤ fasting plasma glucose \< 7.0 mmol/L and（or）7.8 mmol/L ≤ 2 hour plasma glucose \< 11.1 mmol/L and (or) 5.7% ≤ HbA1c\< 6.5%.
2. 18 ≤ Age \<70.

Exclusion Criteria:

1. Patients who can be diagnosed with diabetes mellitus.
2. Patients applying antidiabetic drugs, glucocorticoids, and other drugs that have an effect on blood glucose.
3. Females during pregnancy or lactation.
4. Patients with gastrointestinal disorders, psychiatric disorders, autoimmune disorders, tumors, etc.
5. Patients with acute cardiovascular and (or) cerebrovascular diseases within 6 months prior to study participation.
6. Patients with hepatic dysfunction (ALT, AST, or total bilirubin ≥ 2 times the upper limit of normal), renal dysfunction (creatinine \> the upper limit of normal), and cardiac dysfunction (NYHA class III and IV).

Where this trial is running

Beijing

• China-Japan Friendship Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xiao Ma, MD

Conditions Prediabetes; Nutrigenomics; Nutritional intervention