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Investigating the Influence of Meal Energy Timing and the Proportion of Dietary Fat in Energy Supply on the Health of Individuals with Abnormal Blood Glucose through Digital Intervention:A Two-Center, 2×2 Factorial Design,Cluster Randomized Controlled Trial

Investigating the Influence of Meal Energy Timing and the Proportion of Dietary Fat in Energy Supply on the Health of Individuals with Abnormal Blood Glucose through Digital Intervention:A Two-Center, 2×2 Factorial Design,Cluster Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107392
Enrollment
Unknown
Registered
2025-08-11
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus/prediabetes

Interventions

Intervention group B:The energy distribution of the three meals is 3:5:2, and the fat-to-energy ratio of the diet is 35% throughout the day
Intervention group C:The energy distribution of the three meals is 5:3:2, and the fat-to-energy ratio of the diet is 25% throughout the day
Intervention group A:The energy distribution of the three meals is 3:5:2, and the fat-to-energy ratio of the diet is 25% throughout the day
Intervention group D:The energy distribution of the three meals is 5:3:2, and the fat-to-energy ratio of the diet is 35% throughout the day

Sponsors

Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly screened type 2 diabetes mellitus or prediabetes; 2. Body weight was stable for nearly 6 months; 3. Stable medication in the last 3 months; 4. Proficient in using smartphones; 5. Local resident.

Exclusion criteria

Exclusion criteria: 1. Heart attack or stroke within the past 6 months. 2. Severe liver or kidney diseases. 3. Long-term use of medications affecting blood glucose control (e.g., systemic glucocorticoids, steroids, thiazide diuretics). 4. Cancer diagnosis within the past 2 years. 5. Psychiatric disorders. 6. Conditions affecting energy metabolism or glucose metabolism (Cushing's syndrome, chronic kidney disease, cirrhosis, inflammatory bowel disease, chronic obstructive pulmonary disease, total triglycerides > 500 mg/dL.)

Design outcomes

Primary

MeasureTime frame
HbA1c;—

Secondary

MeasureTime frame
Weight;Fasting blood glucose;Area Under the Curve of the 2-Hour Oral Glucose Tolerance Test;Total Triglycerides;Total Cholesterol;High-Density Lipoprotein;Low-Density Lipoprotein;waistline;fat mass;lean mass;—

Countries

China

Contacts

Public ContactChanghao Sun

Harbin Medical University

sun2002changhao@126.com+86 133 1361 9991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026