Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the effects of the dietary supplement oréVida™ (active ingredient on the basis of a culinary herb)administered twice daily in an acute study on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men and pre-menopausal women, aged 35-50 years, inclusive.
oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. We do not claim that this supplement is meant to treat any ailment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oréVida™ 60mg/day | Experimental |
| |
| oréVida™ 120mg/day (1) | Experimental |
| |
| oréVida™ 120mg/day (2) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oréVida™ | Dietary Supplement | 1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vigilance, Attention, and Concentration Tasks | Cognitive Drug Research (CDR) Test Battery Attention:
| 4 times one day (at each test day, tasks 13 times repeated) |
| Measure | Description | Time Frame |
|---|---|---|
| Working Memory & Executive Function Tasks | CDR Test Battery Memory:
| 4 times one day (at each test day, tasks 7 times repeated) |
| Episodic Secondary Memory Tasks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Kelley, MD | Provident Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provident Clinical Research | Addison | Illinois | 60101 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| oréVida™ | Dietary Supplement | 1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day) |
|
| oréVida™ | Dietary Supplement | 1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day) |
|
| Placebo | Dietary Supplement | 1 capsule of placebo twice a day |
|
CDR Test Battery Memory:
|
| 4 times one day (at each test day, tasks 7 times repeated) |
| Additional Measurements / Questionnaires |
| 4 times one day (at each test day, VAS 13 times repeated / POMS 3 times repeated) |