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| ID | Type | Description | Link |
|---|---|---|---|
| 163042 | Other Identifier | METC |
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| Name | Class |
|---|---|
| Wageningen University and Research | OTHER |
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This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active yoghurt | Active Comparator | Yoghurt snack containing encapsulated lipid |
|
| Placebo yoghurt | Placebo Comparator | Yoghurt snack containing non-encapsulated lipid + empty encapsulation matrix |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active yoghurt | Dietary Supplement | Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured. |
| Measure | Description | Time Frame |
|---|---|---|
| ad libitum food intake | t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake | 2 hours after yoghurt snack |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety feelings | Every 15-30 min, 5 attributes will be measured on a Visual Analogue Scale | Up to 3.5 hours on each of the 2 test days. |
| occurrence and severity of GI symptoms | Every 15-30 min, 4 attributes will be measured on a Visual Analogue Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian AM Masclee, Prof. | azM/UM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Netherlands |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 23, 2017 | |
| Reset | Aug 17, 2018 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2016 | Nov 16, 2017 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 23, 2017 | Aug 17, 2018 |
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| Placebo yoghurt | Dietary Supplement | Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured. |
|
| Up to 3.5 hours on each of the 2 test days. |