Biomedical EnhancementNCT02857829
The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
A study testing CAF+ and Caffeine-alone in people with Biomedical Enhancement, run by Nootrobox, Inc. at 1 site in Netherlands.
Trial summary
Achieving optimal concentration during cognitively demanding tasks is of immense human value. Despite our understanding of the important role that attention, working memory, and fluid intelligence play in professional success, and the huge individual differences in these constructs, the modulation of these cognitive… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomedical Enhancement
- What is being tested?
- CAF+ and Caffeine-alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2017to 24 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5-30
- Willing to sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Achieving optimal concentration during cognitively demanding tasks is of immense human value. Despite our understanding of the important role that attention, working memory, and fluid intelligence play in professional success, and the huge individual differences in these constructs, the modulation of these cognitive domains has not been rigorously studied. From the widespread use of caffeine, to the more questionable and increasing use of prescription medications to achieve peak attention, the tremendous interest in achieving cognitive performance has driven individuals to experiment, often with prescription and illegal drugs. Herein, we aim to standardize and extend the study of attention modulating substances, to identify blends that achieve safe enhancements in attention and working memory. Specific to this proposal, we aim to develop CAF+, a blend of natural and generally regarded as safe compounds to improve attention and working memory in normal, healthy individuals. CAF+ is composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (0.06 mg), and cobalamin (20 mg).
Read the 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.
- Conditions
- Biomedical Enhancement
- Being tested
- CAF+, Caffeine-alone, Placebo
- Keywords
- Cognition, working memory, nootropic, reaction time, healthy individuals, cognitive enhancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF+Dietary supplement
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).
Caffeine-aloneDietary supplement
Caffeine (100 mg)
PlaceboOther
Rice flour
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Caffeine-alone | Active comparator | 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. Receives: Dietary Supplement: Caffeine-alone |
| CAF+ | Experimental | Not described Receives: Dietary Supplement: CAF+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Memory: Immediate recall score
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.
Measured: Up to 12 weeks
Secondary outcomes (5)
Verbal Memory: Delayed recall score
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.
Measured: Up to 12 weeks
Working memory
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.
Measured: Up to 12 weeks
Response inhibition and focused attention
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.
Measured: Up to 12 weeks
Complex-scanning and visual tracking
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.
Measured: Up to 12 weeks
Simple and -choice reaction time
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start1 Mar 2017
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomedical EnhancementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nootrobox, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arjan Blokland, PhD, Principal investigator, Maastricht UniversityAnke Sambeth, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857829
- Sponsor's protocol ID
- Nootrobox_Maastricht
- Status last verified
- Dec 2017
- First submitted
- 30 Jul 2016
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
- ClinicalTrials.gov ID
- NCT02857829
- Acronym / sponsor ID
- Nootrobox_Maastricht
- Conditions
- Biomedical Enhancement
- Keywords
- Cognition, working memory, nootropic, reaction time, healthy individuals, cognitive enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nootrobox, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Achieving optimal concentration during cognitively demanding tasks is of immense human value. Despite our understanding of the important role that attention, working memory, and fluid intelligence play in professional success, and the huge individual differences in these constructs, the modulation of these cognitive domains has not been rigorously studied. From the widespread use of caffeine, to the more questionable and increasing use of prescription medications to achieve peak attention, the tremendous interest in achieving cognitive performance has driven individuals to experiment, often with prescription and illegal drugs. Herein, we aim to standardize and extend the study of attention modulating substances, to identify blends that achieve safe enhancements in attention and working memory. Specific to this proposal, we aim to develop CAF+, a blend of natural and generally regarded as safe compounds to improve attention and working memory in normal, healthy individuals. CAF+ is composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (0.06 mg), and cobalamin (20 mg).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Caffeine-alone | Active comparator | Dietary Supplement: Caffeine-aloneThe 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. |
| CAF+ | Experimental | Dietary Supplement: CAF+ |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18.5-30
- Willing to sign informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAF+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). | Dietary supplement | CAF+ |
| Caffeine-aloneCaffeine (100 mg) | Dietary supplement | Caffeine-alone |
| PlaceboRice flour | Other | Placebo |
Primary outcome
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.
5 secondary outcomes
Verbal Memory: Delayed recall score
Time frame: Up to 12 weeks
Working memory
Time frame: Up to 12 weeks
Response inhibition and focused attention
Time frame: Up to 12 weeks
Complex-scanning and visual tracking
Time frame: Up to 12 weeks
Simple and -choice reaction time
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arjan Blokland, PhD principal investigator
Maastricht University
Anke Sambeth, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAF+ and Caffeine-alone in people with Biomedical Enhancement, run by Nootrobox, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Memory: Immediate recall score (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.