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| Name | Class |
|---|---|
| FrieslandCampina | INDUSTRY |
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Background: Recent advances in science have established a fundamental role for low grade chronic inflammation in mediating all stages of most of the non-communicable diseases associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy and its components are known to exert beneficial effects on postprandial hyperglycemia. This study investigates if dairy, normal and enriched, can reduce chronic inflammation via improvement in glucose regulation.
Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose regulation and postprandial inflammation with the effect of a standard milk drink, within a population of overweight, apparently healthy subjects.
Study design: The study is designed as a double-blind randomized placebo-controlled parallel trial during 7 weeks, during which the test and reference products will be consumed at home.
Main study parameters/endpoints: The difference in absolute change in fasting blood plasma concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the treatment period, between subjects consuming the test and reference product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutrient-enriched milk | Experimental | consumption of 250 ml three times per day |
|
| regular milk | Placebo Comparator | consumption of 250 ml three times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrient-enriched milk | Other |
| ||
| regular milk |
| Measure | Description | Time Frame |
|---|---|---|
| change in fasting blood glucose | baseline and 7 weeks | |
| change in fasting plasma interleukin-6 (IL-6) | baseline and 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| postprandial area under the curve for plasma glucose | 7 weeks | |
| change in fasting insulin | 7 weeks | |
| postprandial area under the curve for plasma insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alwine Kardinaal, PhD | NIZO Food Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIZO food research | Ede | Netherlands |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 7 weeks |
| postprandial area under the curve for plasma IL-6 | 7 weeks |