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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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Nutritional products such as spearmint extract, alpha-glyceryl phosphoryl choline and phosphatidylserine may have anti-oxidative and anti-inflammatory effect that may be effective in improving cognition. This study aims to evaluate the impact of a nutritional product on cognition in healthy teenagers.
There is a growing interest in the nootropic properties of nutritional supplements, especially for improving cognitive processes such as attention, perception, evaluation, and working memory. Spearmint extract, alpha-glyceryl phosphoryl choline, and pyrroloquinoline quinone have antioxidative properties that may contribute to cognitive function, and spearmint extract has demonstrated attention-enhancing effects in young adults and memory-improving effects in elderly population. Phosphatidylserine is a phospholipid found abundantly in the brain that has also been evidenced to be effective in improving cognition.
This randomized, double-blind study will be conducted to determine whether a nutritional supplement containing spearmint extract, phosphatidylserine, alpha-glyceryl phosphoryl choline, and pyrroloquinoline quinone ("Brain Doctors Formula Mega Brain Boost") is safe and effective in improving cognitive function in healthy participants aged 12 to 18 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Experimental | Active ingredients (per tablet): • NeumentixTM Phenolic Complex K110-42:
Inactive ingredients (per tablet):
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| Placebo | Placebo Comparator | Active ingredients (per tablet): N/A Inactive ingredients (per tablet):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational | Dietary Supplement | 2 tablets are taken with water around the same time every day, ideally after a meal |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the impact of test product on the executive cognitive function in healthy adolescents within the group and when compared to the placebo | Change from baseline in national institute of health (NIH) Toolbox Dimension Change Card Test (aged 12+ version) after 3 and 6 weeks. Dimensional Change Card Sort Test is a measure of cognitive flexibility. The scoring range is provided as an age-corrected normative score. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants | after 3 and 6 weeks |
| To determine the impact of test product on the attention and executive cognitive function in healthy adolescents within the group and when compared to the placebo | Change from baseline in NIH Toolbox Flanker Inhibitory Control and Attention Test (12+) after 3 and 6 weeks. The Flanker task measures both attention and inhibitory control. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants | after 3 and 6 weeks |
| To determine the impact of test product on the cognitive processing speed of healthy adolescents within the group and when compared to the placebo | Change from baseline in NIH Toolbox Pattern Comparison Speed Test after 3 and 6 weeks. This test measures speed of cognitive processing. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants | after 3 and 6 weeks |
| To determine the impact of test product on the working memory of healthy adolescents within the group and when compared to the placebo |
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Inclusion Criteria:
Middle, high school, or college students who are 12 to 18 years of age (inclusive).
In good general health (no active or uncontrolled diseases, infections, or conditions) and able to swallow the study products (tablets).
Have normal (or acceptable to the investigator) vital signs (blood pressure and heart rate) at screening.
Individuals of childbearing potential must practice a medically acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
Agree to refrain from treatments listed in protocol in the defined timeframe.
Participant and participant's legally authorized representative (LAR, if applicable) are willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent and assent, be able to understand and perform the assessments, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow evaluations related to cognitive function.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Tartar, Ph.D. | Nova Southeastern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Southeastern University | Fort Lauderdale | Florida | 33314 | United States |
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Randomization at 1:1 ratio for active or placebo
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Double blind
| Placebo | Other | 2 tablets are taken with water around the same time every day, ideally after a meal |
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Change from baseline in the Symmetry Span Task after 3 and 6 weeks. The symmetry span task is a measure of working memory capacity. Scores on the task range from 0-42 with higher scores representing greater working memory capacity
| after 3 and 6 weeks |
| To determine the impact of test product on self reported mind wandering of healthy adolescents within the group and when compared to the placebo | Change from Week 1 in the self assessment of mind wandering, as captured in a study daily diary, after 3 and 6 weeks by using the The Mind Wandering Questionnaire. The Mind Wandering Questionnaire is a retrospective measure of mind wandering in a everyday life. A scoring range is between 1-6. Higher scores on this scale represent greater levels of mind wandering experienced | after 3 and 6 weeks |
| To assess the safety and tolerability of the test product in healthy adolescents | Counting the number of adverse events over the study period | 6 weeks |
| To assess the safety and tolerability of the test product in healthy adolescents | Assessing the type of adverse events (non serious or serious) over the study period | 6 weeks |
| To assess the safety and tolerability of the test product in healthy adolescents | Assessing the severity of adverse events (mild, moderate, severe) over the study period | 6 weeks |