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| Name | Class |
|---|---|
| Eurofins Optimed | INDUSTRY |
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To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.
The primary objective of this study is to assess if a very low energy foam has the same effect on satiety as the same volume of a reference normal energy foam, by testing for equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min of the reference . Two other normal energy foams with slightly different compositions are also compared to the reference foam to test for possible effects of differences in composition (carbohydrate type, emulsifier) other than energy per se.
On each test day, volunteers will arrive at the clinic in a fasted state where they consume a standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours after start of breakfast and consume 400 ml of the test products with a spoon within 10 minutes. Each subject will be randomized to a treatment order according to a balanced (Williams type) design, and receive one of four test products each week for 4 weeks, separated by a one-week washout period (consumed on the same week day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very low energy aerated beverage | Active Comparator | Very low energy aerated beverage |
|
| Normal energy aerated beverage 1 | Active Comparator | Normal energy aerated beverage 1 |
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| Normal energy aerated beverage 2 | Active Comparator | Normal energy aerated beverage 2 |
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| Normal energy aerated beverage 3 | Active Comparator | Normal energy aerated beverage 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low energy aerated beverage | Dietary Supplement |
| ||
| Normal energy aerated beverage 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger and satiety questions | Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale) | Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min |
| Measure | Description | Time Frame |
|---|---|---|
| Electronic Visual Analogue Scale (EVAS) for liking questions | Time point 15 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Blanc, PhD | Eurofins Optimed | Study Director |
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| Dietary Supplement |
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| Normal energy aerated beverage 2 | Dietary Supplement |
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| Normal energy aerated beverage 3 | Dietary Supplement |
|