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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher protein | Experimental |
| |
| Lower protein | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher protein | Other | An acute mixed meal containing higher protein |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Diet Induced Thermogenesis (DIT) AUC | Change in DIT assessed as the area under the curve (AUC) | Pre-consumption (0 minutes) to 300 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| DIT niAUC | Change in DIT assessed as the net incremental area under the curve (niAUC) | Pre-consumption (0 minutes) to 300 minutes |
| Carbohydrate oxidation | Change in carbohydrate oxidation assessed as the AUC and niAUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C. Maki, PhD | MB Clinical Research & Consulting, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Clinical Research | Addison | Illinois | 60101 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Lower protein |
| Other |
An acute mixed meal containing lower protein |
|
| Pre-consumption (0 minutes) to 300 minutes |
| Fat oxidation | Change in fat oxidation assessed as the AUC and niAUC | Pre-consumption (0 minutes) to 300 minutes |
| Respiratory Exchange Ratio (RER) | Change in RER assessed as the AUC and niAUC | Pre-consumption (0 minutes) to 300 minutes |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |