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

NCT05580146 | Completed

• 1 other identifier: 58BX2 and 58BX3
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Change

Keywords

NIRS; Cognitive Performance; Cerebral Blood Flow; Mango Leaf Extract; Zynamite®; Mangifera indica

Outcome Measures

Primary Outcomes (30)

• 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

Study Arms (4)

Zynamite® 15% 150mg

ACTIVE COMPARATOR

Mango leaf extract (Mangifera indica)

Dietary Supplement: Zynamite® 15% 150mg

Zynamite® 15% 300mg

ACTIVE COMPARATOR

Mango leaf extract (Mangifera indica)

Dietary Supplement: Zynamite® 15% 300mg

Zynamite® 15% 600mg

ACTIVE COMPARATOR

Mango leaf extract (Mangifera indica)

Dietary Supplement: Zynamite® 15% 600mg

Placebo

PLACEBO COMPARATOR

Placebo matched for appearance

Dietary Supplement: Placebo

Interventions

Zynamite® 15% 150mg DIETARY_SUPPLEMENT

leaves of the mango food plant

Also known as: Mangifera indica

Zynamite® 15% 150mg

Zynamite® 15% 300mg DIETARY_SUPPLEMENT

leaves of the mango food plant

Also known as: Mangifera indica

Zynamite® 15% 300mg

Zynamite® 15% 600mg DIETARY_SUPPLEMENT

leaves of the mango food plant

Also known as: Mangifera indica

Zynamite® 15% 600mg

Placebo DIETARY_SUPPLEMENT

Sunflower oil matched for appearance

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Northumbria University: lead
• Nektium Pharma SL: collaborator

Study Sites (1)

Brain performance and nutrition research centre, Northumbria university

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Mangifera indica extract

Study Officials

• David Kennedy, Prof

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple masking
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Balanced crossover

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: October 14, 2022
• Study Start: May 17, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)