Cognitive ChangeNCT05580146
Acute Dose-ranging Effects of Mango Leaf Extract (Zynamite® 15%) on Cognitive Function and Cerebral Blood Flow
A study testing Zynamite® 15% 150mg, Zynamite® 15% 300mg and Zynamite® 15% 600mg in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Zynamite® 15% 150mg, Zynamite® 15% 300mg and Zynamite® 15% 600mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2021to 14 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must self-assess themselves as being in good health
- Participants must be aged 18 to 30 years at the time of giving consent
- Participants must self-report playing video-games (arcade, console, computer, smartphone) for not less than 5 hours a week on average, over the previous 6 months .
Who cannot join
- Have symptoms of Covid-19 or fall into the 'high' or 'moderate' risk categories from coronavirus as defined by NHS UK.
- Have any pre-existing diagnosed medical condition/illness which will impact taking part in the study NOTE: the explicit exception to this is controlled hay fever. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance. Note asthma is not permitted in this study.
- Are currently taking prescription medications including habitual use of non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen, aspirin) NOTE: the explicit exceptions to this are contraceptive treatments for female participants, thyroid medication, topical creams and those taken 'as needed' in the treatment of hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-29.9 kg/m2
- Are pregnant, seeking to become pregnant or lactating.
Show all 22Show fewer
- Have learning and/or behavioural difficulties such as dyslexia or ADHD
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Smoke tobacco or vape nicotine or use nicotine replacement products
- Excessive caffeine intake (>500 mg per day)
- Have relevant food intolerances/ sensitivities/ allergies
- Have taken antibiotics within the past 4 weeks
- Have taken dietary supplements e.g. vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised). NOTE: Existing vitamin D use is permitted
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Are unable to complete all of the study assessments
- Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- Sleep disorders or are taking sleep aid medication
- Any known active infections
- Does not have a bank account (required for payment)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: Acute Dose-ranging Effects of Mango Leaf Extract (Zynamite® 15%) on Cognitive Function and Cerebral Blood Flow in Healthy Young Adults
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.
Read the detailed description
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.
- Conditions
- Cognitive Change
- Being tested
- Zynamite® 15% 150mg, Zynamite® 15% 300mg, Zynamite® 15% 600mg, Placebo
- Keywords
- NIRS, Cognitive Performance, Cerebral Blood Flow, Mango Leaf Extract, Zynamite®, Mangifera indica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zynamite® 15% 150mgDietary supplement
Also called Mangifera indica
leaves of the mango food plant
Zynamite® 15% 300mgDietary supplement
Also called Mangifera indica
leaves of the mango food plant
Zynamite® 15% 600mgDietary supplement
Also called Mangifera indica
leaves of the mango food plant
PlaceboDietary supplement
Sunflower oil matched for appearance
| Study group | Role | What they receive |
|---|---|---|
| Zynamite® 15% 150mg | Active comparator | Mango leaf extract (Mangifera indica) Receives: Dietary Supplement: Zynamite® 15% 150mg |
| Zynamite® 15% 300mg | Active comparator | Mango leaf extract (Mangifera indica) Receives: Dietary Supplement: Zynamite® 15% 300mg |
| Zynamite® 15% 600mg | Active comparator | Mango leaf extract (Mangifera indica) Receives: Dietary Supplement: Zynamite® 15% 600mg |
| Placebo | Placebo comparator | Placebo matched for appearance Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow during performance of cognitive tasks
Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume)
Measured: 60 minutes post-dose
Cerebral blood flow at rest
Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume)
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 300 minutes post dose
Change in speed of attention from baseline to 300 minutes post dose
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
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 300 minutes post dose
Cognitive function- change in individual task Accuracy for word recall from baseline to 300 minutes post dose
Task Accuracy
Measured: 0, 300 minutes post dose
Cognitive function- change in individual task Accuracy for word recognition from baseline to 300 minutes post dose
Task Accuracy
Measured: 0, 300 minutes post dose
Cognitive function- change in individual task Accuracy for picture recognition from baseline to 300 minutes post dose
Task Accuracy
Measured: 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
Measured: 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
Measured: 0, 300 minutes post dose
Cognitive function- change in individual task Accuracy for digit vigilance from baseline to 300 minutes post dose
Task Accuracy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 300 minutes post dose
Cognitive Function- change in serial 3 subtractions accuracy from baseline to 300 minutes post dose
Task accuracy
Measured: 0, 300 minutes post dose
Cognitive Function- change in serial 7 subtractions accuracy from baseline to 300 minutes post dose
Task accuracy
Measured: 0, 300 minutes post dose
Cognitive Function- change in Rapid Information Visual Processing accuracy from baseline to 300 minutes post dose
Task accuracy
Measured: 0, 300 minutes post dose
Cognitive Function- change in Rapid Information Visual Processing reaction time from baseline to 300 minutes post dose
Reaction time
Measured: 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
Measured: 0, 300 minutes post dose
Mental fatigue- change in subjective mental fatigue from baseline to 300 minutes post dose
Mental fatigue visual analogue scale
Measured: 0, 300 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start17 May 2021
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Balanced crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Nektium Pharma SL
- Responsible party
- Sponsor
- Investigators
- David Kennedy, Prof, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580146
- Sponsor's protocol ID
- 58BX2 and 58BX3
- Status last verified
- Apr 2022
- First submitted
- 5 May 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Dose-ranging Effects of Mango Leaf Extract (Zynamite® 15%) on Cognitive Function and Cerebral Blood Flow in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05580146
- Acronym / sponsor ID
- 58BX2 and 58BX3
- Conditions
- Cognitive Change
- Keywords
- NIRS, Cognitive Performance, Cerebral Blood Flow, Mango Leaf Extract, Zynamite®, Mangifera indica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Nektium Pharma SL
- Study start
- 17 May 2021 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Balanced crossover
| Arm | Type | Receives |
|---|---|---|
| Zynamite® 15% 150mg | Active comparator | Dietary Supplement: Zynamite® 15% 150mgMango leaf extract (Mangifera indica) |
| Zynamite® 15% 300mg | Active comparator | Dietary Supplement: Zynamite® 15% 300mgMango leaf extract (Mangifera indica) |
| Zynamite® 15% 600mg | Active comparator | Dietary Supplement: Zynamite® 15% 600mgMango leaf extract (Mangifera indica) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo matched for appearance |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must self-assess themselves as being in good health
- Participants must be aged 18 to 30 years at the time of giving consent
- Participants must self-report playing video-games (arcade, console, computer, smartphone) for not less than 5 hours a week on average, over the previous 6 months .
Key exclusion criteria (22 listed)
- Have symptoms of Covid-19 or fall into the 'high' or 'moderate' risk categories from coronavirus as defined by NHS UK.
- Have any pre-existing diagnosed medical condition/illness which will impact taking part in the study NOTE: the explicit exception to this is controlled hay fever. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance. Note asthma is not permitted in this study.
- Are currently taking prescription medications including habitual use of non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen, aspirin) NOTE: the explicit exceptions to this are contraceptive treatments for female participants, thyroid medication, topical creams and those taken 'as needed' in the treatment of hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-29.9 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zynamite® 15% 150mgAlso: Mangifera indicaleaves of the mango food plant | Dietary supplement | Zynamite® 15% 150mg |
| Zynamite® 15% 300mgAlso: Mangifera indicaleaves of the mango food plant | Dietary supplement | Zynamite® 15% 300mg |
| Zynamite® 15% 600mgAlso: Mangifera indicaleaves of the mango food plant | Dietary supplement | Zynamite® 15% 600mg |
| PlaceboSunflower oil matched for appearance | Dietary supplement | Placebo |
Primary outcome
Cerebral blood flow during performance of cognitive tasks
Time frame: 60 minutes post-dose
Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume)
Cerebral blood flow at rest
Time frame: 10 minutes
Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume)
Change in speed of performance from baseline to 300 minutes post dose
Time frame: 0, 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
Change in accuracy of cognitive task performance from baseline to 300 minutes post dose
Time frame: 0, 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
Change in accuracy of attention from baseline to 300 minutes post dose
Time frame: 0, 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
Change in speed of attention from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
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
Change in working memory from baseline to 300 minutes post dose
Time frame: 0, 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
Change in speed of memory from baseline to 300 minutes post dose
Time frame: 0, 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
Change in episodic memory from baseline to 300 minutes post dose
Time frame: 0, 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
Cognitive function- change in individual task Accuracy for word recall from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Accuracy for word recognition from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Accuracy for picture recognition from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Accuracy for numeric working memory from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Accuracy for choice reaction time from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Accuracy for digit vigilance from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Accuracy for corsi blocks task from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Accuracy for peg and ball from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task Accuracy
Cognitive function- change in individual task Reaction Time for picture recognition from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Reaction Time
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
Time frame: 0, 300 minutes post dose
Reaction Time
Cognitive function- change in individual task Reaction Time for numeric working memory from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Reaction Time
Cognitive function- change in individual task Reaction Time for choice reaction time from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Reaction Time
Cognitive function- change in individual task Reaction Time for digit vigilance from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Reaction Time
Cognitive function- change in individual task Reaction Time for simple reaction time from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Reaction Time
Cognitive function- change in individual task Reaction Time for peg and ball from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Reaction Time
Cognitive Function- change in serial 3 subtractions accuracy from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task accuracy
Cognitive Function- change in serial 7 subtractions accuracy from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task accuracy
Cognitive Function- change in Rapid Information Visual Processing accuracy from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Task accuracy
Cognitive Function- change in Rapid Information Visual Processing reaction time from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Reaction time
Cognitive Function- change in Rapid Information Visual Processing false alarms from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Number of false alarms
Mental fatigue- change in subjective mental fatigue from baseline to 300 minutes post dose
Time frame: 0, 300 minutes post dose
Mental fatigue visual analogue scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kennedy, Prof principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zynamite® 15% 150mg, Zynamite® 15% 300mg and Zynamite® 15% 600mg in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow during performance of cognitive tasks (time frame: 60 minutes post-dose). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.