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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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The objective of this trial is to assess the effects of a 7-day diet containing inulin vs. a control diet on energy expenditure in adults with overweight/obesity or normal weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin - high fiber | Experimental |
| |
| Control - Low Fiber | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Fiber bar with Inulin | Other | Bar with inulin - high fiber |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Energy Expenditure | Measured in kcal/day | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Measure | Description | Time Frame |
|---|---|---|
| Diet Induced Thermogenesis | Assessed as the AUC and niAUC during the full test period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Diet Induced Thermogenesis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C Maki, PhD | MB Clinical Research and 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 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Low fiber bar - no inulin |
| Other |
Bar without inulin - low fiber |
|
Assessed as the AUC and niAUC during the breakfast period |
| Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Diet Induced Thermogenesis | Assessed as the AUC and niAUC during the lunch period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial carbohydrate oxidation rate | Assessed as the AUC and niAUC during the full test period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial carbohydrate oxidation rate | Assessed as the AUC and niAUC during the breakfast period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial carbohydrate oxidation rate | Assessed as the AUC and niAUC during the lunch period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial fat oxidation rate | Assessed as the AUC and niAUC during the full test period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial fat oxidation rate | Assessed as the AUC and niAUC during the breakfast period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial fat oxidation rate | Assessed as the AUC and niAUC during the lunch period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial respiratory exchange ration (RER) | Assessed as the AUC and niAUC during the full test period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial respiratory exchange ration (RER) | Assessed as the AUC and niAUC during the breakfast period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Postprandial respiratory exchange ration (RER) | Assessed as the AUC and niAUC during the lunch period | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Fasting Carbohydrate Oxidation | Assessed from pre-consumption | pre-consumption |
| Fasting Fat Oxidation | Assessed from pre-consumption | pre-consumption |
| Fasting RER | Assessed from pre-consumption | pre-consumption |
| Fat Mass | Measured using the Styku body scanner. | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| Fat-Free Mass | Calculated by subtracting fat mass from body mass. | Measured on days 7 and 21 where days 1 and 15 are the first day of study product intake for each treatment. Day 7 to 14 is the washout period. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |