NCT05960396

Exploring the Mechanism of Dietary Pattern Improving MAFLD

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

investigators plan to observe the changes of biochemical indicators, body composition, gut microbiota, metabolomics in patients at different periods through balanced diet and Low-carbohydrate diet, so as to determine the beneficial "intestinal functional group" of MAFLD, and provide basis for the selection of the best time for probiotics and fecal bacteria transplantation.By comparing the response of the main outcome indicators to the two dietary structures, personalized nutritional intervention measures can be achieved.

Detailed description

1. Balanced diet group: carbohydrates 50% -65%, fats 20% -30%, and proteins 10% -15%, among which proteins mainly come from beans, soy products, nuts, milk, poultry meat, aquatic products, and animal meat (lean); Lipids mainly come from Unsaturated fat acids, reducing the intake of Saturated fat acids; Carbohydrates mainly come from staple foods, with a combination of coarse and fine staple foods； 2. Low-carbohydrate diet intervention : carbohydrate 20% -40%, fat 30% -45%, protein 30% -40%. The protein mainly comes from beans, soy products, nuts, milk, meat, etc; Lipids mainly come from Unsaturated fat acids, reducing the intake of Saturated fat acids; Carbohydrates mainly come from low GI foods.

Conditions

• NAFLD
• Diet Habit

Interventions

Type	Name	Description
BEHAVIORAL	Diet intervention	investigators use different diet intervention to observe the changes of biochemical indicators, body composition, Gut microbiota, metabonomics, etc. for patients with MAFLD during different periods

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-04-01
• Completion: 2025-12-30
• First posted: 2023-07-25
• Last updated: 2023-07-25