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
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients diagnosed with type 2 diabetes and NAFLD.

• Age between 18 and 75 years.

• Body mass index (BMI) \> 18.0 kg/m2

• Weight stable for at least 3 months prior to the study (gain or loss \<4kg).

• Stable treatment for at least 3 months with 1-3 oral

• antidiabetic medications (with or without insulin therapy), or not yet receiving antidiabetic medication prior to the beginning of the study.

• Able to give written informed consent.

Locations
Other Locations
China
Hunan Shanshui physical examination center
RECRUITING
Changsha
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
RECRUITING
Changsha
Physical Examination Center of Gezhouba central hospital of Sinopharm
RECRUITING
Yichang
Contact Information
Primary
Wu Luo
luowubio@163.com
+86-0731-8461-5293
Time Frame
Start Date: 2022-06-05
Estimated Completion Date: 2026-06-05
Participants
Target number of participants: 120
Treatments
Experimental: Experimental: CMNT diet
The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle
No_intervention: Usual Care
Dietary recommendations based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the control group
Sponsors
Leads: State Key Laboratory of Subhealth Intervention Technology

This content was sourced from clinicaltrials.gov