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| Name | Class |
|---|---|
| Université Catholique de Louvain | OTHER |
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The aim of this study is to confirm by a randomized double-blind controlled study the interest of a combination of saffron (Saffr'Activ®) and scutellaria (Scutell'up®) on the regulation of mood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saffron extract | Active Comparator |
| |
| Scutellaria baicalensis extract | Active Comparator |
| |
| Saffron and Scutellaria baicalensis extract | Active Comparator |
| |
| Placebo (maltodextrin) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saffron extract | Dietary Supplement | Food supplements are taken during 6 weeks by healthy volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluated mood regulation | observe a difference of the Beck Inventory Depression (BDI) score (adjusted for baseline), after 6 weeks of supplementation. All items are scored on a 4-point scale, ranging from 0 to 3. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluated mood regulation | Beck Inventory Depression (BDI) score. All items are scored on a 4-point scale, ranging from 0 to 3. | 3 and 6 weeks of intervention and after 2 weeks after the end of intervention |
| Evaluated mood regulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie Dormal, PhD | Université Catholique de Louvain | Study Chair |
| Louise Deldicque, Pr | Université Catholique de Louvain | Study Director |
| Laurent Simar, Dr | Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université Catholique de Louvain, CICN | Ottignies-Louvain-la-Neuve | 1348 | Belgium |
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| ID | Term |
|---|---|
| C499814 | Scutellaria baicalensis extract |
| C008315 | maltodextrin |
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| Scutellaria baicalensis extract | Dietary Supplement | Food supplements are taken during 6 weeks by healthy volunteers |
|
| Saffron and Scutellaria baicalensis extract | Dietary Supplement | Food supplements are taken during 6 weeks by healthy volunteers |
|
| Placebo (maltodextrin) | Dietary Supplement | Food supplements are taken during 6 weeks by healthy volunteers |
|
Hamilton depression rating scale (HAMD) score. HAMD is composed of 21 items. The scoring is based on the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
| after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention |