- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06689644
Effect of a Plant Based Nootropic on Perceptual Decision Making.
November 13, 2024 updated by: Dr Andrea Utley, University of Leeds
Effect of a Plant-based Nootropic Supplement on Perceptual Decision-making and Brain Network Interdependencies: a Randomised, Double-blinded and Placebo-controlled Study.
Nootropics are a group of medicinal substances purported to improve important cognitive functions such as learning, focus and memory.
Many of these substances have demonstrated beneficial effects on cognitive performance and overall health.
However, a thorough understanding of how these substances and their synergistic effects in the form of a supplement may benefit fundamental brain processes is currently lacking.
In the current study, we will investigate the effects of a plant-based, nootropic supplement (https://uk.mindlabpro.com/)
on perceptual decision-making (i.e. the ability to make rapid decisions based on sensory stimuli) in healthy adult participants.
Study Overview
Status
Completed
Conditions
Detailed Description
Participants will perform a computerised cognitive task assessing their perceptual decision-making pre- and post- 60 days of continuous supplementation with either a plant-based nootropic supplement (Mind Lab pro) or placebo.
During testing, electroencephalography (EEG) signals will be captured simultaneously.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leeds, United Kingdom
- Faculty of Biological sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Eligibility screening of participants was guided by the following inclusion criteria: (i) be between 20-59 years old, (ii) be right-handed and (iii) be able to cease taking other dietary supplements for two months.
Exclusion Criteria:
- Exclusion criteria included: (i) currently consuming a nootropic supplement, (ii) any known musculoskeletal, or neurological medical conditions or cognitive impairments (iii) have a known diagnosis of epilepsy/history of seizures and (iv) have a known hearing or visual condition that affects daily life function.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
This group will receive the nootropic supplement for 60 days.
|
Commercially available product: Mind lab pro
A computerised cognitive task involving rapid visual categorisation of images
Brain signals are recorded from a 64 channel EEG system during the cognitive task
|
|
Placebo Comparator: Control group
This group will receive a placebo supplement for 60 days
|
A computerised cognitive task involving rapid visual categorisation of images
Brain signals are recorded from a 64 channel EEG system during the cognitive task
A cellulose commonly used as a bulking agent in supplement products
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptual decision-making performance
Time Frame: Pre- and post- 60 days of supplementation
|
Choice accuracy and reaction times
|
Pre- and post- 60 days of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain network interdependencies
Time Frame: Pre- and post- 60 days of supplementation
|
Patterns extracted from brain signals using electroencephalography
|
Pre- and post- 60 days of supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ioannis Delis, University of Leeds
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2023
Primary Completion (Actual)
March 6, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
November 13, 2024
First Submitted That Met QC Criteria
November 13, 2024
First Posted (Estimated)
November 14, 2024
Study Record Updates
Last Update Posted (Estimated)
November 14, 2024
Last Update Submitted That Met QC Criteria
November 13, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUtley
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No further investigations will take place using this data with anyone outside of the current research group
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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