Acute Effects of Mango Leaf Extract (Zynamite®) on Cognitive Function, Mood and Stress

NCT04299217 | Completed

• 1 other identifier: 58BX1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effects of a single dose of Zynamite® 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. Seventy-two healthy healthy males (50%) and females (50%) aged 18-45 years will be recruited from the general population. Participants will be randomised to receive either Zynamite® or placebo at testing visit 1, then the treatment they have not already received at testing visit 2. A single acute dose will be administered on each of the two testing visits, with at least a seven day washout period in between. The study is quantitative; participants will complete questionnaires assessing mood, cognitive tasks and an Observed Multitasking Stressor (OMS) task (with saliva samples, and blood samples for 50% of the sample). The cognitive/mood assessments will take place at baseline, then at 30, 180 and 300 minutes post-dose. The OMS assessments will take place at baseline then between 90 and 130 minutes post-dose. For participants in the bloods sub-sample, blood samples will be taken at baseline and after the 300 minute post-dose assessment. Both testing visits will be identical apart from the treatment allocated.

Conditions

Cognitive Change; Stress

Keywords

cognition; cognitive performance; stress; nutrition; memory; attention; mental performance; mood

Outcome Measures

Primary Outcomes (16)

• Mood measures- Profile of Mood States (POMS)

  Profile of Mood States (POMS)

  Prior to (baseline) and following one dose of treatment (at 30, 180 and 300 minutes post dose)

• Mood measures- Stress Visual Analogue Scales (VAS)

  Stress Visual Analogue Scales (VAS) (out of 100; higher score is more anxious/stressed/relaxed/calm) (pre-dose baseline and 30, 180 and 300 min post dose

  Following one dose of treatment at 30, 180 and 300 minutes post-dose

• Mood measures- State Trait Anxiety Inventory (STAI)

  State Trait Anxiety Inventory (STAI) (20-80; higher is more anxious) (pre-OMS at baseline and 90 - 130 min post-dose).

  Following one dose of treatment at 90-130 minutes post-dose

• Cognitive Function- Individual task

  Individual task parameters including word recall, word recognition, picture recognition, stroop, peg and ball, numeric working memory, digit vigilance, choice reaction time, simple reaction time, corsi blocks (pre-dose baseline and 30, 180 and 300 min post-dose)

  Following one dose of treatment at 30, 180 and 300 min post-dose

• Cognitive Function- Composite cognitive factors

  Composite cognitive factors of the aforementioned tasks e.g. Episodic memory, Working Memory, Attention, Spatial Working Memory, Executive Function, Episodic Memory (pre-dose baseline and 30, 180 and 300 min post-dose)

  Following one dose of treatment at 30, 180 and 300 min post-dose

• Cognitive Function- cognitively demanding tasks

  Cognitive function and mental fatigue during extended performance of cognitively demanding tasks (Cognitive Demand Battery \[comprising mental arithmetic and attention tasks\] (pre-dose baseline and 30, 180 and 300 min post-dose)

  Following one dose of treatment at 30, 180 and 300 min post-dose

• Cognitive Function under stressful conditions

  Cognitive performance (multi tasking using Serial 7s and tracking simultaneously) during acute stress as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose).

  Following one dose of treatment at 90-130 mins post-dose

• Psychological stress response

  Modulation of the psychological response to acute stress (change in: Stress on the aforementioned mood measures during the OMS) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose).

  Following one dose of treatment at 90-130 mins post-dose

• Physiological stress response- Galvanic Skin Response

  Modulation of the physiological response to acute stress (change in galvanic skin response) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose)

  Following one dose of treatment at 90-130 mins post-dose

• Physiological stress response- Heart Rate

  Modulation of the physiological response to acute stress (change in heart rate) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose)

  Following one dose of treatment at 90-130 mins post-dose

• Physiological stress response- BDNF Blood Markers

  Plasma levels of BDNF (brain-derived neurotrophic factor) taken pre and post-treatment

  Following one dose of treatment

• Physiological stress response- Adrenaline Blood Markers

  Plasma levels of adrenaline taken pre and post-treatment

  Following one dose of treatment

• Physiological stress response- Noradrenaline Blood Markers

  Plasma levels of noradrenaline taken pre and post-treatment

  Following one dose of treatment

• Physiological stress response- Serum Prolactin Blood Markers

  Serum levels of Prolactin taken pre and post-treatment

  Following one dose of treatment

• Physiological stress response- α-amylase Salivary Response

  Levels of α-amylase before and after acute stress (OMS)

  Following one dose of treatment at 90-130 mins post-dose

• Physiological stress response- Cortisol Salivary Response

  Levels of salivary cortisol before and after acute stress (OMS)

  Following one dose of treatment at 90-130 mins post-dose

Study Arms (2)

Mango Leaf Extract

ACTIVE COMPARATOR

300 mg Mangifera indica (mango) leaf extract standardized to ≥ 60% mangiferin (Zynamite®), plus carrier

Dietary Supplement: Zynamite®

Placebo

PLACEBO COMPARATOR

Carrier (placebo)

Other: Placebo

Interventions

Zynamite® DIETARY_SUPPLEMENT

Zynamite® is a novel mango (Mangifera indica) leaf extract standardized to contain 60% of the polyphenol mangiferin. Zynamite® is classified as a food or food supplement and is available for purchase within the EU. Zynamite® is not associated with any significant deleterious side effects.

Mango Leaf Extract

Placebo OTHER

Placebo comparator (carrier)

Placebo

Eligibility Criteria

• Age: 18 Years - 45 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
• Aged 18 to 45 years at the time of giving consent

You may not qualify if:

• Participants are not eligible to take part if they:
• Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are 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.
• Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive treatments for female participants, and those taken 'as needed' in the treatment of asthma and 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 159 mm Hg or diastolic over 99 mm Hg)
• Have a Body Mass Index (BMI) outside of the range 18.5-35 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
• Have taken antibiotics within the past 4 weeks
• Have taken dietary supplements eg. 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 taken are out of choice and not medically prescribed or advised)
• 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

Study Officials

• David Kennedy, Prof

  david.kennedy@northumbria.ac.uk

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principle Invstigator

Model Details: Balanced crossover

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: March 6, 2020
• Study Start: November 4, 2019
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

GB (1)