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| Name | Class |
|---|---|
| OmniActive Health Technologies | INDUSTRY |
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Comparison of Capsimaxâ„¢ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.
Capsimaxâ„¢ is a capsicum extract in a bead technology to avoid oral and gastric burning. Capsimaxâ„¢ 2mg, Capsimaxâ„¢ 4 mg and placebo was initially given as a single dose on an empty stomach with measures of metabolic rate, and satiety before and after and food intake at 1 hour after Capsimaxâ„¢.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsimax 2 mg | Active Comparator | single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
|
| Placebo | Placebo Comparator | single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
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| Capsimax 4 mg plus 250 kcal meal | Active Comparator | single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
|
| Placebo plus 250 kcal meal | Placebo Comparator | single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsimax | Dietary Supplement | Capsimax |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Metabolic Rate | Metabolic cart measurement difference before and after intervention | up to 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction) | Difference in area under the curve from baseline of the Mean Visual Analog. Each question on the scale ranges from 0 to 100 mm. The two ends of the scale are anchored by the highest and lowest values (e.g. "the hungriest I have ever been" to "no hunger at all"). Some questions have high values on the right and others have high values on the left. Each question (hunger, fullness, prospective food intake and satisfaction) is a sub-scale. Each sub-scale is scored separately. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects excluded will:
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| Name | Affiliation | Role |
|---|---|---|
| Frank L Greenway, MD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Term |
|---|---|
| D062407 | Meals |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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4 arm crossover trial
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Supplement and placebo capsules with identical appearance
| Placebo |
| Dietary Supplement |
Placebo |
|
| Meal | Other | Meal |
|
| Baseline to 4 hours |
| Food Intake | Meal with unlimited portions | 1 hour after intervention |