Status:
COMPLETED
Acute Effects of Mango Leaf Extract (Zynamite®) on Cognitive Function, Mood and Stress
Lead Sponsor:
Northumbria University
Collaborating Sponsors:
Nektium Pharma SL
Conditions:
Cognitive Change
Stress
Eligibility:
All Genders
18-45 years
Phase:
NA
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 dur...
Detailed Description
The proposed study will 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 a...
Eligibility Criteria
Inclusion
- Participants must self-assess themselves as being in good health
- Aged 18 to 45 years at the time of giving consent
Exclusion
- 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
- 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
- Have oral disease
- Any known active infections
- Does not have a bank account (required for payment)
- Are non-compliant with regards treatment consumption (see 4.3)
- Participants will be excluded from the blood sampling element of the study if:
- Have any known active infections
- They currently have, previously have had or think they are at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus (HIV)
- They have ever had breast cancer and/or a mastectomy
- They have haemophilia or any similar clotting/blood disorder
- They have they had unprotected sexual intercourse with any person from an HIV high risk population
- They have ever been involved in intravenous drug use
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04299217
Start Date
November 4 2019
End Date
March 17 2020
Last Update
March 11 2021
Active Locations (1)
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1
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST