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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
26
Controlled High FODMAP diet (15g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period
Controlled low FODMAP diet (3g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period
Prince of Wales Hospital
Shatin, Hong Kong
Differences in postprandial glycemia
incremental area under curve on continuous glucose monitoring post meal
Time frame: 10 days
Glucose response to 75g oral glucose tolerance test
fasting and postchallenge plasma glucose
Time frame: 10 days
Insulin response to 75g oral glucose tolerance test
insulin levels
Time frame: 10 days
Change in alpha diversity of gut microbiota
Changes in alpha diversity in gut microbiota
Time frame: 10 days
Change in beta diversity of gut microbiota
Changes in beta diversity in gut microbiota
Time frame: 10 days
Body weight
Differences in body weight between arms
Time frame: 10 days
Gastrointestinal symptoms
Measured on visual analogue scale 1-10 for each item, higher score indicates worse symptoms
Time frame: 10 days
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