NCT05628584

High FODMAP Diet With Metformin in preDM

The Impact of High or Low FODMAP Diets on Postprandial Glucose Response and Gut Microbiota in Individuals With Prediabetes Treated With Metformin: A Randomized Crossover Controlled-Feeding Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Elaine Chow · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, double blinded, randomised cross over feeding trial examine high or low FODMAP diet in combination with metformin on postprandial glucose responses and gastrointestinal tolerability and gut microbiota profiles. The trial will compare high or low FODMAP diet, each of 10 days duration in combination with 5 days metformin, separated by a washout period of at least 2 weeks.

Conditions

• PreDiabetes
• Impaired Glucose Tolerance

Interventions

Type	Name	Description
COMBINATION_PRODUCT	High FODMAP diet with metformin	Controlled High FODMAP diet (15g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period
COMBINATION_PRODUCT	Low FODMAP diet with metformin	Controlled low FODMAP diet (3g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period

Timeline

• Start date: 2022-11-11
• Primary completion: 2023-08-25
• Completion: 2023-10-15
• First posted: 2022-11-28
• Last updated: 2025-03-05

Locations

1 site across 1 country: Hong Kong