NCT07083336

Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease (Version 3.0)

Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: State Key Laboratory of Subhealth Intervention Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the efficacy of CMNT, an intermittent energy restriction (iER) intervention, in managing Chinese adults with type 2 diabetes and non-alcoholic fatty liver disease. An interim analysis will be added to the planned 120-participant CMNT intervention program to compare intervention efficacy with the usual care control group and assess potential risks associated with dietary interventions.

Detailed description

Study Protocol Amendments (v3.0) are as follows: 1. Addition of Interim Analysis. Rationale: The purpose of adding an interim analysis is to evaluate the effectiveness of the CMNT dietary intervention during this clinical trial, while also assessing participant compliance and the safety of the energy-restricted diet. 2. Expansion of BMI Inclusion Criteria. The BMI inclusion criterion was revised from "18-35" to " \> 18" (removing the upper limit) to include patients with higher BMI values. Rationale: In clinical practice, some patients with a BMI over 35 have shown interest in participating in this study. After evaluation by physicians, these patients can be included. 3. Increase in the Number of Multicenter Sites. The number of centers increased from 3 to 6. Rationale: Expanding the number of multicenter sites accelerates participant recruitment. Given the study's focus on patients with T2D and NAFLD, the recruitment of patients with comorbidities is relatively challenging. Additionally, expanding the number of centers enhances the generalizability of the study's conclusions, making them applicable to patients in more regions. 4. Clarification and Revision of Secondary Objectives and Corresponding Evaluation Criteria. Addition of metabolomics content to identify key metabolites in CMNT intervention; Screening for key microbial taxa post - CMNT intervention based on gut microbiota results; Validation of the causal relationship between diet and gut microbiota using fecal transplantation; Rationale: Incorporating gut microbiota and metabolomics indicators helps better explore the mechanism of CMNT dietary intervention in this population. 5. The participant recruitment period has been extended to May 5, 2026. Rationale: Due to the severe COVID-19 pandemic during 2022-2023, coupled with the fact that this study focuses on comorbidities, the number of eligible participants has been significantly lower compared to studies involving general T2D patients. Furthermore, as most individuals currently do not prioritize fatty liver screening, participant recruitment has progressed more slowly than anticipated. Therefore, an extension of the recruitment period is necessary.

Conditions

• Type 2 Diabetes Mellitus
• Metabolic Dysfunction-associated Steatotic Liver Disease

Interventions

Type	Name	Description
OTHER	CMNT diet	Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet

Timeline

• Start date: 2022-06-05
• Primary completion: 2026-05-05
• Completion: 2026-06-05
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

3 sites across 1 country: China