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The physical properties of a food product, such as its gelling properties in the stomach can influence how full a person may feel after its consumption. Decreasing appetite feeling through consumption of such a product with a low energy content may contribute to weight management.
The study will assess if a drink with gelation properties in the stomach can reduce appetite and therefore contribute to weight management.
This is a single-center, double-blinded, 4 arm cross-over randomized controlled study looking to enroll 24 adult participants. The study will be performed at the Clinical Innovation Lab (CIL), Nestlé Research, Lausanne. Enrolled participants will have 4 visit days after the screening visit. They will consume one of the test products, or control at each visit and complete the study assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Product 1 | Active Comparator | Protein & Fiber - Variant 1 |
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| Interventional Product 2 | Active Comparator | Protein & Fiber - Variant 2 |
|
| Interventional Product 3 | Active Comparator | Protein & Fiber - Variant 3 |
|
| Comparator | Placebo Comparator | Protein & Fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beverage Variant 1 (low gelation properties) | Dietary Supplement | The first interventional product for this study is a drink containing protein and fiber at a concentration 1. It will come in a ready to drink format for the participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Area Under the Curve (iAUC) of the composite appetite score (CAS) | Incremental Area Under the Curve (iAUC) of the composite appetite score (CAS) derived from a 100 mm visual analogue scale (VAS) questionnaire on appetite. | Time frame used to assess product difference are -5, +15, +30, +45, +60, +90, +120 minutes post product intake. Time frame collection is -120, -90, -60, -30, -5, +15, +30, +45, +60, +90, +120min post product intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal (GI) smart questionnaire score | Time frame used to assess product difference is -5, +30, +60, +90 and +120 minutes post product intake. However, time frame for collection is -120, -60, -5, +30, +60, +90 and +120 minutes post product intake. | |
| GI hormones (ghrelin, GLP-1, PYY, GIP, CCK) levels postprandial and quantity of an ad libitum meal consumption 2hs after product intake and throughout the rest of the day |
| Measure | Description | Time Frame |
|---|---|---|
| Blood insulin and blood amino acid levels | 5 minutes before IP intake and 15, 30, 45, 60, 90 and 120 minutes after IP intake | |
| iCmax and Tmax of the CAS. | 0-120 min ICmax and Tmax of the postprandial CAS |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Innovation Lab - Nestlé Research | Lausanne | Switzerland |
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| Beverage Variant 2 (medium gelation properties) | Dietary Supplement | The first interventional product for this study is a drink containing protein and fiber at a concentration 2. It will come in a ready to drink format for the participants. |
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| Beverage Variant 3 (high gelation properties) | Dietary Supplement | The first interventional product for this study is a drink containing protein and fiber at a concentration 3. It will come in a ready to drink format for the participants. |
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| Control group (no gelation property) | Other | The control product for this study is a drink containing protein and fiber. It will come in a ready to drink format for the participants. |
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| 5 minutes before IP intake and 15, 30, 45, 60, 90 and 120 minutes after IP intake |
| iAUC of the composite appetite score (CAS) | From -120, -90, -60, -30, -5 minutes before IP consumption to +15, 30, 60, 90 and 120 minutes after IP consumption, at V1, V2, V3 and V4 |
| From -120, -90, -60, -30, -5 minutes before IP consumption to +15, 30, 60, 90 and 120 minutes after IP consumption, at V1, V2, V3 and V4 |
| Individual components of the composite VAS scores in response the 4 products | From -120 minutes before IP intake to +120 minutes after IP intake atV1, V2, V3 and V4 |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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