Dietary Protein Sources and Glycemic Variability
NCT Number: NCT06525441
Acronym: ProG
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Disease|Diabetes|Overweight|Obesity|Dietary Protein
Sponsor: Guangdong Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-02-01

Summary:
This goal of trial is to evaluate the effects of plant-based vs. animal-based diets on glycemic variability in overweight or obese adults through a 3-week dietary intervention.

The main question it aims to answer is:

Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared with an animal-based diet?

Participants will strictly follow a designated plant-based or animal-based dietary regimen throughout the duration of the 3-week study. They will wear a Continuous Glucose Monitor (CGM) throughout the study, engage in weekly clinical assessments, and record their daily dietary intake.

Primary Outcome Measures: Change in Mean Amplitude of Glycemic Excursion (MAGE), Continuous Glucose Monitoring (CGM) will measure the Mean Amplitude of Glycemic Excursion (MAGE)., From enrollment to the end of intervention at 3 weeks
Secondary Outcome Measures: Change in fasting blood-glucose, From enrollment to the end of intervention at 3 weeks|Change in fasting insulin, From enrollment to the end of intervention at 3 weeks|Change in mean glucose levels, From enrollment to the end of intervention at 3 weeks|Change in total daily time above range, \>7.8 mmol/L, From enrollment to the end of intervention at 3 weeks|Change in total daily time below range, \<3.9 mmol/L, From enrollment to the end of intervention at 3 weeks|Change in range of total daily time, 3.9 \~7.8 mmol/L, From enrollment to the end of intervention at 3 weeks|Change in glycemic variability, From enrollment to the end of intervention at 3 weeks|Change in glycemic standard deviation, From enrollment to the end of intervention at 3 weeks|Change in insulin sensitivity, From enrollment to the end of intervention at 3 weeks|Change in β cell function, From enrollment to the end of intervention at 3 weeks|Change in Large Amplitude of Glycemic Excursions (LAGE), From enrollment to the end of intervention at 3 weeks|Change in Area Under Curve (AUC), From enrollment to the end of intervention at 3 weeks|Change in body weight, From enrollment to the end of intervention at 3 weeks|Change in waist-to-hip ratio, From enrollment to the end of intervention at 3 weeks|Change in body composition, From enrollment to the end of intervention at 3 weeks|Change in blood lipids, From enrollment to the end of intervention at 3 weeks|Change in uric acid, From enrollment to the end of intervention at 3 weeks|Change in gut microbiome, From enrollment to the end of intervention at 3 weeks|Change in renal function, From enrollment to the end of intervention at 3 weeks|Change in systolic blood pressure, From enrollment to the end of intervention at 3 weeks|Change in diastolic blood pressure, From enrollment to the end of intervention at 3 weeks