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The overall objective of this research is to determine the digestive faith and health impact of protein and fiber rich foods in different food matrices in type 2 diabetes risk population. This is achieved by controlled postprandial intervention where plasma amino acids, lipids, glucose metabolism, bile acids and microbial metabolites are evaluated as well as fecal microbiota and metabolites.
Detailed research aim of this controlled, randomized crossover postprandial clinical study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal 1 | Experimental | Meal with plant protein and fiber in an intact structure |
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| Meal 2 | Experimental | Meal with plant protein and fiber, where the cell structure is broken |
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| Meal 3 | Placebo Comparator | Low protein and low fiber cereal |
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| Meal 4 | Experimental | High protein and low carbohydrate bread with animal proteins |
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| Meal 5 | Experimental | High protein and low carbohydrate bread with plant protein |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High fiber and protein meal | Dietary Supplement | In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma amino acids | Plasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal. | 0-4 hours |
| Gut derived metabolites | Gut derived metabolites are measured with untargeted metabolomics from plasma at 12 hours after consuming the study meal. From fecal sample, the metabolomics are measured at 24 hours after consuming the study meal. Plasma short chain fatty acids are quantified at 12 hours after consuming the study meal. | 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | Plasma glucose is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal. | 0-4 hours |
| Inflammation marker | Plasma IL-22 is measured at 0, 60, 240 minutes after consuming the study meal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjukka Kolehmainen, Professor | Contact | 0403553617 | marjukka.kolehmainen@uef.fi | |
| Moona Partanen, Msc | Contact | +358 504759536 | moona.partanen@uef.fi |
| Name | Affiliation | Role |
|---|---|---|
| Marjukka Kolehmainen, Professor | University of Eastern Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Eastern Finland | Recruiting | Kuopio | 70211 | Finland |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
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| Control | Dietary Supplement | The control meal is low fiber and low protein meal. |
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| 0-4 hours |
| Plasma triglycerides | Plasma triglycerides are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal. | 0-4 hours |
| Urine para-cresol | The amount of para-cresol is measured from urine sample at 24 hours after consuming the study meal. | 24 hours |
| Plasma insulin | Plasma insulin is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal. | 0-4 hours |
| Plasma free fatty acids | Plasma free fatty acids are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal. | 0-4 hours |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |