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| Name | Class |
|---|---|
| Maastricht University | OTHER |
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This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.
The aim of this study is to determine the suitability of a continuous glucose monitor to detect the impact of a dietary intervention on postprandial blood glucose levels in normal, healthy, free living subjects. We will compare a dietary intervention of meals with a high glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low post-meal blood glucose) in a cross-over study. In addition, the glucose profiles obtained both via venous blood sampling and via continuous glucose monitor following a standard carbohydrate load will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low glycemic load | Experimental | Low glycemic load |
|
| High glycemic load | Experimental | High glycemic load |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low glycemic load | Dietary Supplement | Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post prandial glucose concentration | Difference in glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after the three main meals (breakfast, lunch, dinner) during both dietary interventions will be calculated. The nine post prandial periods for both low and high glycemic load diet per subject will be combined in the mixed model. | 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner) |
| Measure | Description | Time Frame |
|---|---|---|
| Three-day glucose concentration | Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared | From start of dietary intervention until the end 3 days later |
| Day time glucose concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Carry over of the dietary intervention into the next day | Difference in glucose (in venous blood) and insulin responses to a standard meal consumed on the day after both the low and high glycemic load diets. 2-hour post prandial Incremental are under the curve for glucose and insulin in venous blood will be calculated. | 0 - 120 minutes after the standard meal |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mensink Ronald P, PhD | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Netherlands |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| High glycemic load | Dietary Supplement | High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days |
|
Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared |
| Between 07:00-22:00 h |
| Night time glucose concentration | Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared | Between 22:01-26:59 h |
| Glucose variability | The Continuous Overall Net Glycemic Action (CONGA) will be calculated. | From start of dietary intervention until the end 3 days later |
| Comparison of continuous interstitial glucose with venous blood glucose | Bland-Altman plots of venous blood glucose plotted against the continuous interstitial glucose at the closest available time point. Standard meal will be 200 grams of rice consumed on the day after both the low and high glycemic load diets | -30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal |
| Carry over as measured in venous blood versus as measured during continuous glucose monitoring | Compare the difference in glucose responses to the standard meal on morning after the low and the high glycemic load diet measured in venous blood with the difference as measured in using continuous blood glucose monitor. 2-hour post prandial incremental area under the curve for glucose will be calculated for both methods. | 0 - 120 minutes after the standard meal |
| Post prandial glucose concentration during breakfast, lunch or dinner. | Difference in post prandial glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after each of the three main meals (breakfast, lunch, dinner) during the three-day dietary interventions will be calculated separately. The three post prandial periods for both low and high glycemic load diet per subject will be combined in separate mixed models for breakfast, a model for lunch and a model for dinner. | 0 - 120 minutes after each of the start of the meal |