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It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.
Rationale: It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. Differences in small intestine microbiota are hypothesized to be key in explaining the interpersonal differences in glycemic responses.
Objective: To investigate the role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products.
Study design: The subjects will wear a continuous glucose monitor during the screening and the study. First a screening (14 days in total) will take place with to choose the test products (2 out of 4) that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. Also an OGTT will be performed. The study will be a randomized cross-over trial with two test days (length of trial is 6 days in total). During the trial, the subjects will be intubated with a naso-jejunum catheter.
Study population: Twenty men or women (BMI≥25 kg/m2, 40-75 years old). Intervention (if applicable): Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test.
Main study parameters/endpoints: test (food) product-induced plasma glucose responses (iAUC), small intestine microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbohydrate-rich food product (to be determined) | Experimental | This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates. |
|
| Another carbohydrate-rich food product (to be determined) | Experimental | This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| food product | Other | a food product containing 50 gram carbohydrates |
|
| Measure | Description | Time Frame |
|---|---|---|
| postprandial glucose response (iAUC) per test product | iAUC glucose | 0-120 minutes |
| small intestine microbiome | the relative composition (%) and the functional capacity (%) of the small intestine microbiota | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| macronutrients in the small intestinal aspirates | amounts of carbohydrates, proteins, fats | 0-240 minutes |
| presence and production of (bacterial) degradation products in the small intestinal aspirates |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University | Wageningen | Gelderland | Netherlands |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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concentrations of organic acids and short-chain fatty acids
| 0-240 minutes |
| digestive enzymes in the small intestinal aspirates | concentrations of amylase | 0-240 minutes |
| non-absorbable marker in the small intestinal aspirates | peg-4000 concentrations | 0-240 minutes |
| blood HbA1c | concentrations of HbA1c | 0-240 minutes |
| blood glucose | concentrations glucose (e.g. GLP-1, PYY) | 0-240 minutes |
| blood insulin | concentrations of insulin | 0-240 minutes |
| blood glucagon | concentrations of glucagon | 0-240 minutes |
| blood total triglycerides | concentrations of triglycerides | 0-240 minutes |
| blood total free fatty acids | concentrations of free fatty acids | 0-240 minutes |
| plasma gut hormones | concentrations of gut hormones (e.g. GLP-1, PYY) | 0-240 minutes |
| breath 13C-lactosyl ureide | concentrations of 13C-lactosyl ureide | 0-240 minutes |
| breath hydrogen | concentrations of hydrogen (ppm) | 0-240 minutes |
| breath methane | concentrations of methane (ppm) | 0-240 minutes |
| Oral microbiome composition | microbiota relative composition (%) | baseline |
| Salivary α-amylase | concentrations of a-amylase | 0-240 minutes |
| Fecal microbiota composition | microbiota relative composition (%) | baseline |
| D009750 |
| Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |