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| Name | Class |
|---|---|
| Nektium Pharma SL | INDUSTRY |
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Zynamite® is a novel mango (Mangifera indica) leaf extract standardized to contain polyphenol mangiferin.It has previously been shown to enhance brain oxygenation, physical performance and ergogenic parameters following ischemia-reperfusion in healthy humans when consumed alongside other polyphenols. Preliminary data has also indicated that a single 300mg dose of Zynamite® (60%) can improve performance across a range of cognitive tasks.This study aims to evaluate the effects, in healthy adults, of 3 doses of Zynamite® 15% on performance across a number of cognitive domains, as well as during a period of cognitively demanding task performance. A second sub-study will assess cerebral blood flow during cognitively demanding task performance.
Extracts made from the leaves of the mango food plant (Mangifera indica L., Anacardiaceae) have a long history of medicinal usage, most likely due to particularly high levels of the polyphenol mangiferin. Zynamite®, is a novel mango (Mangifera indica) leaf extract standardized to contain polyphenol mangiferin which has previously been shown to enhance brain oxygenation and physical performance and ergogenic parameters following ischemia-reperfusion in healthy humans when consumed alongside other polyphenols.A recent study in rats demonstrated a similar effect of Zynamite® on electrophysiological (EEG) spectral power as that seen following caffeine, with a synergistic effect of co-consumption of Zynamite® and caffeine. A concomitant ex vivo study demonstrated increased long-term potentiation (LTP) in rat hippocampal slices, suggesting the potential for Zynamite® to enhance memory. Previous research has also demonstrated that both single doses and chronic administration of polyphenols can beneficially modulate cognitive function, including during cognitively demanding task performance. Previous research has also shown that polyphenols and polyphenol rich treatments can modulate cerebral blood-flow. These findings raise the possibility that Zynamite® may have beneficial effects on psychological and hemodynamic parameters, potentially with some similarities to the effects exerted by caffeine.
A recent study expanded on the above assessing the effects of a single dose of Zynamite® (60% of polyphenol mangiferin) on performance across a number of cognitive domains (attention, working memory, episodic memory, executive function), as well as during a period of cognitively demanding task performance, and during laboratory-induced stress. The results showed that a single dose of 300 mg Zynamite® significantly improved performance accuracy across the tasks in the battery, with domain-specific effects seen in terms of enhanced performance on an 'Accuracy of Attention' factor and an 'Episodic Memory' factor as well as improved performance across all three tasks (Rapid Visual Information Processing, Serial 3s and Serial 7s subtraction tasks) of the Cognitive Demand Battery sub-section of the assessment, which assesses cognitive function and subjective mental fatigue during sustained performance of mentally demanding tasks. All of these cognitive benefits were seen across the post-dose assessments (30 min, 3 h, 5 h). These results provide the first demonstration of cognition enhancement following consumption of mango leaf extract adding to previous research showing that polyphenols and polyphenol rich extracts can improve brain function.
The proposed studies will expand on the existing body of research by assessing the effects of three doses of Zynamite® (this time a lower concentration version containing 15% polyphenol mangiferin) on cognitive performance and cerebral blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zynamite® 15% 150mg | Active Comparator | Mango leaf extract (Mangifera indica) |
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| Zynamite® 15% 300mg | Active Comparator | Mango leaf extract (Mangifera indica) |
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| Zynamite® 15% 600mg | Active Comparator | Mango leaf extract (Mangifera indica) |
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| Placebo | Placebo Comparator | Placebo matched for appearance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zynamite® 15% 150mg | Dietary Supplement | leaves of the mango food plant |
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| Measure | Description | Time Frame |
|---|---|---|
| Cerebral blood flow during performance of cognitive tasks | Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume) | 60 minutes post-dose |
| Cerebral blood flow at rest | Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume) | 10 minutes |
| Change in speed of performance from baseline to 300 minutes post dose | This is a composite measure derived from summing the z score reaction time (RT) performance on seven tasks and finding the average: Speed of performance = (Zsimple RT + Zchoice RT + Zdigit vigilance RT + ZRVIP RT + ZNumeric working memory RT + ZPicture recognition RT + ZWord recognition RT) ÷ 7 | 0, 300 minutes post dose |
| Change in accuracy of cognitive task performance from baseline to 300 minutes post dose | This is a composite measure derived from summing the z score accuracy performance scores on nine tasks and finding the average: Accuracy of performance = (Zaccuracy choice RT + Zdigit vigilance accuracy + ZRVIP accuracy + ZNumeric working memory accuracy + ZCorsi span score + Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy) ÷ 9 | 0, 300 minutes post dose |
| Change in accuracy of attention from baseline to 300 minutes post dose | This is a composite measure derived from averaging the sum of the the z score accuracy performance scores from the choice reaction time, digit vigilance and Rapid visual information processing tasks | 0, 300 minutes post dose |
| Change in speed of attention from baseline to 300 minutes post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kennedy, Prof | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain performance and nutrition research centre, Northumbria university | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
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| ID | Term |
|---|---|
| C501277 | Mangifera indica extract |
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Balanced crossover
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Triple masking
| Zynamite® 15% 300mg | Dietary Supplement | leaves of the mango food plant |
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| Zynamite® 15% 600mg | Dietary Supplement | leaves of the mango food plant |
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| Placebo | Dietary Supplement | Sunflower oil matched for appearance |
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This is a composite measure derived from averaging the sum of the the z score reaction times from the choice reaction time, digit vigilance and Rapid visual information processing tasks |
| 0, 300 minutes post dose |
| Change in working memory from baseline to 300 minutes post dose | This is a composite measure derived from averaging the sum of the z score accuracy performance on the numeric working memory task and Corsi block-tapping task | 0, 300 minutes post dose |
| Change in speed of memory from baseline to 300 minutes post dose | This is a composite measure derived from averaging the sum of the z score reaction times on the numeric working memory task, the delayed picture recognition task and the delayed word recognition task | 0, 300 minutes post dose |
| Change in episodic memory from baseline to 300 minutes post dose | This is a composite measure derived from averaging the sum of the z score performance on the following cognitive tasks: immediate word recall, delayed word recall, delayed picture recognition, delayed word recognition | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for word recall from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for word recognition from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for picture recognition from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for numeric working memory from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for choice reaction time from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for digit vigilance from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for corsi blocks task from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Accuracy for peg and ball from baseline to 300 minutes post dose | Task Accuracy | 0, 300 minutes post dose |
| Cognitive function- change in individual task Reaction Time for picture recognition from baseline to 300 minutes post dose | Reaction Time | 0, 300 minutes post dose |
| Change in Reaction Time for word recognition from baseline to 300 minutes post dose Cognitive function- individual task Reaction Time for word recognition Cognitive function- individual task Reaction Time for word recognition | Reaction Time | 0, 300 minutes post dose |
| Cognitive function- change in individual task Reaction Time for numeric working memory from baseline to 300 minutes post dose | Reaction Time | 0, 300 minutes post dose |
| Cognitive function- change in individual task Reaction Time for choice reaction time from baseline to 300 minutes post dose | Reaction Time | 0, 300 minutes post dose |
| Cognitive function- change in individual task Reaction Time for digit vigilance from baseline to 300 minutes post dose | Reaction Time | 0, 300 minutes post dose |
| Cognitive function- change in individual task Reaction Time for simple reaction time from baseline to 300 minutes post dose | Reaction Time | 0, 300 minutes post dose |
| Cognitive function- change in individual task Reaction Time for peg and ball from baseline to 300 minutes post dose | Reaction Time | 0, 300 minutes post dose |
| Cognitive Function- change in serial 3 subtractions accuracy from baseline to 300 minutes post dose | Task accuracy | 0, 300 minutes post dose |
| Cognitive Function- change in serial 7 subtractions accuracy from baseline to 300 minutes post dose | Task accuracy | 0, 300 minutes post dose |
| Cognitive Function- change in Rapid Information Visual Processing accuracy from baseline to 300 minutes post dose | Task accuracy | 0, 300 minutes post dose |
| Cognitive Function- change in Rapid Information Visual Processing reaction time from baseline to 300 minutes post dose | Reaction time | 0, 300 minutes post dose |
| Cognitive Function- change in Rapid Information Visual Processing false alarms from baseline to 300 minutes post dose | Number of false alarms | 0, 300 minutes post dose |
| Mental fatigue- change in subjective mental fatigue from baseline to 300 minutes post dose | Mental fatigue visual analogue scale | 0, 300 minutes post dose |