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

NCT04299217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-03-11

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Zynamite®

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.

OTHER

Placebo

Placebo comparator (carrier)

Sponsors & Collaborators

  • Nektium Pharma SL

    collaborator INDUSTRY

  • Northumbria University

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-03-17
Completion
2020-03-17

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04299217 on ClinicalTrials.gov