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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High FODMAP | Experimental |
| |
| LOW FODMAP | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High FODMAP diet with metformin | Combination Product | Controlled High FODMAP diet (15g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in postprandial glycemia | incremental area under curve on continuous glucose monitoring post meal | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose response to 75g oral glucose tolerance test | fasting and postchallenge plasma glucose | 10 days |
| Insulin response to 75g oral glucose tolerance test | insulin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40745466 | Derived | Chu NHS, Ling J, Poon EWM, Lee JYS, Song Q, Zuo Z, Muir J, Chan JCN, Chow E. Combining a diet rich in fermentable carbohydrates with metformin improves glycaemic control and reshapes the gut microbiota in people with prediabetes. Nat Metab. 2025 Aug;7(8):1614-1629. doi: 10.1038/s42255-025-01336-4. Epub 2025 Jul 31. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000092724 |
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| Low FODMAP diet with metformin | Combination Product | Controlled low FODMAP diet (3g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period |
|
| 10 days |
| Change in alpha diversity of gut microbiota | Changes in alpha diversity in gut microbiota | 10 days |
| Change in beta diversity of gut microbiota | Changes in beta diversity in gut microbiota | 10 days |
| Body weight | Differences in body weight between arms | 10 days |
| Gastrointestinal symptoms | Measured on visual analogue scale 1-10 for each item, higher score indicates worse symptoms | 10 days |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |