CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
High FODMAP diet with metformin +1 morecombination
Likely dose
High FODMAP diet with metformin 15gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05628584
NCT05628584N/ACompleted
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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

Elaine Chow·interventional·Posted Nov 28, 2022·Updated Mar 5, 2025

In Brief

A clinical study evaluating High FODMAP diet with metformin and Low FODMAP diet with metformin for PreDiabetes and Impaired Glucose Tolerance. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreDiabetes, Impaired Glucose Tolerance
CountriesHong Kong
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 28, 2022
Enrollment StartNov 11, 2022
Primary CompletionAug 25, 2023
Study CompletionOct 15, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.6 years ago

Interventions

High FODMAP diet with metformincombination

Controlled High FODMAP diet (15g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period

Low FODMAP diet with metformincombination

Controlled low FODMAP diet (3g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period