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This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative control | No Intervention | Water | |
| Positive control | Active Comparator | Non-alcoholic beer solids |
|
| Intervention 1 | Experimental | Malt ingredient I |
|
| Intervention 2 | Experimental | Malt ingredient II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malt ingredient | Dietary Supplement | Solution with malt-derived ingredient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prolactinotrophic effect | Δ of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water | 2 hours post consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerability | • Gastro-intestinal tolerability assessment with a visual analogue scale for each symptom of interest i.e.1) Abdominal discomfort 2) Nausea 3) Vomiting 4) Diarrhoea 5) ↓appetite. | 2 hours post consumption |
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Inclusion Criteria:
Subjects who have/are
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose M. Ramos Nieves, M.Sc.; Ph.D. | Société des Produits Nestlé S.A./NIHS | Principal Investigator |
| Pamela Sun | Société des Produits Nestlé S.A./CIL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Société des produits Nestlé/Metabolic Unit | Lausanne | 1000 | Switzerland |
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| Non-alcoholic beer solids | Dietary Supplement | Solution with non-alcoholic beer solids |
|