- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02857829
The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: There is still a great need to find treatments that can improve cognitive function in people that suffer from memory and attention problems, as well as healthy, young individuals. There are various natural ingredients that have been claimed to improve cognitive functions in humans (e.g., caffeine, L-theanine, vinpocetine). These ingredients have a different mechanism of action and are assumed to have a general effect on brain function. It is hypothesized that a combination of these natural ingredients may be more effective to improve cognitive performance. In this study we would like to test the cognition-enhancing potential of a mixture of different natural ingredients.
Objective: Examine the effects of a treatment that consists of different natural ingredients on cognitive performance in young healthy subjects. These effects will be compared with caffeine treatment, a natural ingredient that has been found to improve cognition in various studies.
Study design: This study will use a double-blind placebo controlled, cross-over design.
Study population: Twenty-one healthy subjects in the age range from 18-35 years will be included.
Intervention: The subjects will be tested three times. At each test session they will receive one capsule (Placebo, Caffeine, or CAF+).
Main study parameters/endpoints: The primary outcome measure is the number of recalled words in a verbal word learning task.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The subjects who will be included in the study will visit the testing site four times (medical screening + practice session, and three test sessions). Each testing session will last 2.5 h. In total the subjects will spent about 10 h when they participate. During the three test sessions the subjects will receive a capsule that contains a placebo, caffeine or a combination of different natural ingredients. These treatments are well tolerated. No adverse reactions of treatment are expected. The subjects have to abstain from drinking coffee and smoking the evening before the test days. The results of this study will reveal whether a combination of different natural ingredients is more effective than coffee to improve cognitive functions. In the light of a great demand for finding treatments that can be beneficial for old subjects suffering from age-related cognitive impairments, it is considered that the risks are minimal and there is a considerable potential benefit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Maastricht, Netherlands
- Maastricht University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI between 18.5-30
- Willing to sign informed consent
Exclusion Criteria:
- Suffer from or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness (Also those volunteers who have a first-degree relative with a psychiatric disorder or a history with a psychiatric disorder will be excluded)
- Alcohol consumption >20 drinks/week
- pregnant or lactating
- use of medication of than oral contraceptives
- use of recreation drugs 2 weeks before until the end of the experiment
- any motor or sensory deficits which could reasonably be expected to affect test performance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Rice flour
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Active Comparator: Caffeine-alone
The effects of the combination will be compared to both placebo and caffeine-alone, to test the hypothesis that the blend of ingredients will enhance cognitive measures greater than the most commonly used cognitive enhancer, caffeine.
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Caffeine (100 mg)
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Experimental: CAF+
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CAF+ will be a blend consisting of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (1 mg), and cobalamin (20 mg).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal Memory: Immediate recall score
Time Frame: Up to 12 weeks
|
Verbal Memory will be assessed by an adjusted version of the Rey Auditory Verbal Learning Test (Lezak, 1995): the visual verbal learning test (Riedel, Klaassen, Deutz, van Someren, & van Praag, 1999).
This test consists of a list of 30 Dutch monosyllabic words (18 nouns, 12 adjectives) of which subjects have to remember as many as possible.
All words are presented one by one on a computer screen, in three trials with the same item sequence.
After each trial, the subjects are asked to name as many words as they can (immediate recall).
Thirty minutes after the third trial, the subject is requested to recall as many words as possible (delayed recall).
Next to the delayed recall, a recognition test will be assessed, consisting of all former and 30 comparable new words.
Subjects are asked to respond whether they have seen the word during the learning trials by means of pressing a "yes" or a "no" button.
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Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal Memory: Delayed recall score
Time Frame: Up to 12 weeks
|
Thirty minutes after the third trial of the Verbal Learning Task, the subject is requested to recall as many words as possible (delayed recall).
Next to the delayed recall, a recognition test will be assessed, consisting of all former and 30 comparable new words.
Subjects are asked to respond whether they have seen the word during the learning trials by means of pressing a "yes" or a "no" button.
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Up to 12 weeks
|
Working memory
Time Frame: Up to 12 weeks
|
Working memory will be assessed by the n-back task.
The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence.
The load factor n can be adjusted to make the task more or less difficult.
In this study, we use a 0-back, 1-back and 2-back task, in which the 0-back is a simple focused attention/speed task and the 1- and 2-back require accessing information from working memory.
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Up to 12 weeks
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Response inhibition and focused attention
Time Frame: Up to 12 weeks
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The Stroop task will be used for this measure.
It is well known for its ability to induce interference, and assesses response inhibition and focused attention.
In this task, colour names (in Dutch) are printed in coloured ink; in the congruent category, the colour name and the colour of the ink are the same, in the incongruent category they are not.
The subjects have to name the colour of the ink, not the words themselves.
However, because of the urge to read the printed words (even if one is asked to ignore them) interference occurs.
Since the printed words and ink colour differ in the incongruent category, interference is larger in this category than in the congruent category; this is called the 'Stroop effect' and is known to remain even after extended practices.
The colours used in this task are in blue, red, green and yellow.
The colour of the ink has to be named by pressing one out of four buttons, which each represent one of the colours.
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Up to 12 weeks
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Complex-scanning and visual tracking
Time Frame: Up to 12 weeks
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The digit-symbol substitution task will be used for this measure as follows: The screen shows a series of 9 numbered symbols that represent a "key" The participant is then presented with a series of parallel boxes that contain a symbol in the top half of the box.
He or she must provide a "number" response for the bottom half by referring to the key.
The score is calculated by how many corrects responses can be made within 90 s.
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Up to 12 weeks
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Simple and -choice reaction time
Time Frame: Up to 12 weeks
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The task is divided into two parts.
First the participant must react as soon as the button enlightens in the centre of the response box, by pressing that button.
In the second part one of three possible buttons will light up.
The participant is instructed to respond as quickly as possible.
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Up to 12 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart Rate
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Blood Pressure
Time Frame: Up to 12 weeks
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Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arjan Blokland, PhD, Maastricht University
- Principal Investigator: Anke Sambeth, PhD, Maastricht University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nootrobox_Maastricht
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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