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The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory performance (executive function, associative, spatial and verbal memory) as well as on mood and attention parameters after four, eight and eleven weeks of supplementation and in comparison with placebo.
cogniVida™ 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. The investigators do not claim that this supplement is meant to treat any ailment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cogniVida™ 100 mg/day | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cogniVida™ 100 mg/day | Dietary Supplement | 4 capsules 25 mg (total 100 mg) cogniVida™ once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Associative / Visual Memory (Name to Face Recall (COMPASS)) | Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 1 month | Day 0 (baseline) to day 28 |
| Associative / Visual Memory (Name to Face Recall (COMPASS)) | Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 2 months | Day 0 (baseline) to day 56 |
| Associative / Visual Memory (Name to Face Recall (COMPASS)) | Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 3 months | Day 0 (baseline) to day 77 |
| Visual Memory (Picture Recognition (COMPASS)) | Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 1 month | Day 0 (baseline) to day 28 |
| Visual Memory (Picture Recognition (COMPASS)) | Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 2 months | Day 0 (baseline) to day 56 |
| Visual Memory (Picture Recognition (COMPASS)) | Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 3 months | Day 0 (baseline) to day 77 |
| Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS)) |
| Measure | Description | Time Frame |
|---|---|---|
| Attention and Concentration (Choice Reaction Time (COMPASS)) | Attention and Concentration Tasks on a computer. Outcome measurement: Change of speed of response from baseline to 1 month. | Day 0 (baseline) to day 28 |
| Attention and Concentration (Choice Reaction Time (COMPASS)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kennedy, Prof | Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK | Principal Investigator |
| Crystal Haskell, PhD | Associate Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University | Newcastle upon Tyne | NE1 8ST | United Kingdom |
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| Placebo | Dietary Supplement | 4 capsules of placebo identical to cogniVida™ once a day |
|
Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 1 month |
| Day 0 (baseline) to day 28 |
| Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS)) | Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 2 months | Day 0 (baseline) to day 56 |
| Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS)) | Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 3 months | Day 0 (baseline) to day 77 |
| Working and Spatial Memory ('Corsi Blocks'(COMPASS)) | Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 1 month | Day 0 (baseline) to day 28 |
| Working and Spatial Memory ('Corsi Blocks'(COMPASS)) | Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 2 months | Day 0 (baseline) to day 56 |
| Working and Spatial Memory ('Corsi Blocks'(COMPASS)) | Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 3 months | Day 0 (baseline) to day 77 |
| Executive Function and Verbal Memory (Peg and Ball Task (COMPASS)) | Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 1 month | Day 0 (baseline) to day 28 |
| Executive Function and Verbal Memory (Peg and Ball Task (COMPASS)) | Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 2 months | Day 0 (baseline) to day 56 |
| Executive Function and Verbal Memory (Peg and Ball Task (COMPASS)) | Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 3 months | Day 0 (baseline) to day 77 |
| Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS)) | Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 1 month | Day 0 (baseline) to day 28 |
| Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS)) | Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 2 months | Day 0 (baseline) to day 56 |
| Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS)) | Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 3 months | Day 0 (baseline) to day 77 |
Attention and Concentration Tasks on a computer. Outcome measurement: Change of speed of response from baseline to 2 months. |
| Day 0 (baseline) to day 56 |
| Attention and Concentration (Choice Reaction Time (COMPASS)) | Attention and Concentration Tasks on a computer. Outcome measurement: Change of speed of response from baseline to 3 months. | Day 0 (baseline) to day 77 |
| Attention and Concentration (Rapid Visual Information Processing (COMPASS)) | Attention and Concentration Tasks on a computer. Outcome measurement: Change of accuracy, false alarms, speed of response from baseline to 1 month. | Day 0 (baseline) to day 28 |
| Attention and Concentration (Rapid Visual Information Processing (COMPASS)) | Attention and Concentration Tasks on a computer. Outcome measurement: Change of accuracy, false alarms, speed of response from baseline to 2 months. | Day 0 (baseline) to day 56 |
| Attention and Concentration (Rapid Visual Information Processing (COMPASS)) | Attention and Concentration Tasks on a computer. Outcome measurement: Change of accuracy, false alarms, speed of response from baseline to 3 months. | Day 0 (baseline) to day 77 |
| Bond-Lader Visual Analog Scales (VAS) of Mood | This questionnaire of 16 analogue scales derives three factors that assess change in self-rated alertness, self-rated calmness and self-rated contentment. (presented within COMPASS) Outcome measurement: Change of these parameters from baseline to 1 month. | Day 0 (baseline) to day 28 |
| Bond-Lader Visual Analog Scales (VAS) of Mood | This questionnaire of 16 analogue scales derives three factors that assess change in self-rated alertness, self-rated calmness and self-rated contentment. (presented within COMPASS) Outcome measurement: Change of these parameters from baseline to 2 months. | Day 0 (baseline) to day 56 |
| Bond-Lader Visual Analog Scales (VAS) of Mood | This questionnaire of 16 analogue scales derives three factors that assess change in self-rated alertness, self-rated calmness and self-rated contentment. (presented within COMPASS) Outcome measurement: Change of these parameters from baseline to 3 months. | Day 0 (baseline) to day 77 |
| Profile of Mood States (POMS) Questionnaire | The POMS provides scales of tension-anxiety, depression-dejection, anger -hostility, vigor-activity, fatigue-inertia and confusion-bewilderment. A score will be obtained from each and a single score of "mood disturbance" will be computed. (paper and pencil) Outcome measurement: Change of these parameters from baseline to 1 month. | Day 0 (baseline) to day 28 |
| Profile of Mood States (POMS) Questionnaire | The POMS provides scales of tension-anxiety, depression-dejection, anger -hostility, vigor-activity, fatigue-inertia and confusion-bewilderment. A score will be obtained from each and a single score of "mood disturbance" will be computed. (paper and pencil) Outcome measurement: Change of these parameters from baseline to 2 months. | Day 0 (baseline) to day 56 |
| Profile of Mood States (POMS) Questionnaire | The POMS provides scales of tension-anxiety, depression-dejection, anger -hostility, vigor-activity, fatigue-inertia and confusion-bewilderment. A score will be obtained from each and a single score of "mood disturbance" will be computed. (paper and pencil) Outcome measurement: Change of these parameters from baseline to 3 months. | Day 0 (baseline) to day 77 |
| Prospective and Retrospective Memory Questionnaire (PRMQ) | Subjects will be asked about their subjective 'prospective' and 'retrospective' memory performance - paper and pencil Outcome measurement: Change of memory scores from baseline to 1 month. | Day 0 (baseline) to day 28 |
| Prospective and Retrospective Memory Questionnaire (PRMQ) | Subjects will be asked about their subjective 'prospective' and 'retrospective' memory performance - paper and pencil Outcome measurement: Change of memory scores from baseline to 2 months. | Day 0 (baseline) to day 56 |
| Prospective and Retrospective Memory Questionnaire (PRMQ) | Subjects will be asked about their subjective 'prospective' and 'retrospective' memory performance - paper and pencil Outcome measurement: Change of memory scores from baseline to 3 months. | Day 0 (baseline) to day 77 |