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Clinical TrialID 1320

Acute Dose-ranging Effects of Mango Leaf Extract (Zynamite® 15%) on Cognitive Function and Cerebral Blood Flow

NCT05580146

Cognitive Change

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Record Fields

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Clinical Trial Id
1320
Evidence Id
1320
Core Evidence Id
1320
Source Clinical Trial Id
1301
Herb2 Clinical Trial Id
HBCT001301
Nct Id
NCT05580146
Title
Acute Dose-ranging Effects of Mango Leaf Extract (Zynamite® 15%) on Cognitive Function and Cerebral Blood Flow
Status
Completed
Phase
Study Result
No
Study Condition
Cognitive Change
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Intervention
DIETARY_SUPPLEMENT: Zynamite® 15% 150mg|DIETARY_SUPPLEMENT: Zynamite® 15% 300mg|DIETARY_SUPPLEMENT: Zynamite® 15% 600mg|DIETARY_SUPPLEMENT: Placebo
Intervention Allocation
Randomized
Intervention Model
Crossover
Intervention Mask
Triple
Intervention Purpose
Other
Gender
All
Age
Adult
Enrollment
62
Outcome Measure
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, 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
Sponsor Collaborator
Northumbria University|Nektium Pharma SL
Funded By
OTHER
Location
Brain performance and nutrition research centre, Northumbria university, Newcastle upon Tyne, Tyne And Wear, NE1 8ST, United Kingdom
Other Id
58BX2 and 58BX3
Start Date
2021-05-17
Primary Completion Date
2022-04-14
Completion Date
2022-04-14
First Posted
2022-10-14
Results First Posted
Last Update Posted
2022-10-14
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05580146
Title Cn
Title En
Acute Dose-ranging Effects of Mango Leaf Extract (Zynamite® 15%) on Cognitive Function and Cerebral Blood Flow
Bilingual Status
semi_complete