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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
44
1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day)
1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day)
1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day)
1 capsule of placebo twice a day
Provident Clinical Research
Addison, Illinois, United States
Vigilance, Attention, and Concentration Tasks
Cognitive Drug Research (CDR) Test Battery Attention: * Simple Reaction Time (Speed (msec)) * Digit Vigilance (Speed (msec)/ Targets detected (%)) * Choice Reaction Time(Speed (msec))
Time frame: 4 times one day (at each test day, tasks 13 times repeated)
Working Memory & Executive Function Tasks
CDR Test Battery Memory: * Numeric Working Memory (Sensitivity (SI); Speed (msec)) * Spatial Working Memory (Sensitivity (SI); Speed (msec))
Time frame: 4 times one day (at each test day, tasks 7 times repeated)
Episodic Secondary Memory Tasks
CDR Test Battery Memory: * Immediate Word Recall (Words correctly recalled (%)) * Delayed Word Recall (Words correctly recalled (%) * Word Recognition (Sensitivity (SI); Speed (msec)) * Picture Recognition (Sensitivity (SI); Speed (msec))
Time frame: 4 times one day (at each test day, tasks 7 times repeated)
Additional Measurements / Questionnaires
* Bond-Lader Visual Analog Scale (VAS) of Mood and Alertness * Profile of Mood States (POMS) Questionnaire
Time frame: 4 times one day (at each test day, VAS 13 times repeated / POMS 3 times repeated)
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