Cognitive AssessmentNCT07319117
Evaluation of the Impact of a Nutritional Formulation on Cognitive Performance Following Stress Exposure.
A study testing Skoshify 'Think Tank' Formulation in people with Cognitive Assessment and Working Memory, run by Leeds Beckett University at 1 site in United Kingdom.
Trial summary
The proposed project will evaluate the synergistic effects of a nutritional formulation, 'Think Tank' on cognitive performance following exposure to a psychological and physical stressor. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Assessment, Working Memory, Executive Function (Cognition)
- What is being tested?
- Skoshify 'Think Tank' Formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide written informed consent (in English)
- Aged 40-60
- Female
- Daily caffeine drinkers
- Healthy and free from significant physical and psychiatric disorders
Who cannot join
- Current cigarette smokers/vapers.
- Known food allergy or intolerance to the investigational products or control products.
- Not willing to consume coffee.
- Individuals diagnosed with psychiatric/mental health conditions.
- Individuals engaging in recreational drug use.
- Individuals with diagnosed cardiovascular conditions (e.g. heart disease, high blood pressure)
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- Individuals taking prescribed medication except contraceptives/hormone replacement therapy
- Individuals suffering from Raynaud's or circulatory issues
- Individuals who have suffered an injury or infection in their hand/arm in the last month
- Individuals who have suffered from chronic pain conditions or experience extreme numbness or pain in response to cold temperatures.
- Previous brain injury/brain surgery
- Individuals who work night shifts.
- Currently pregnant or breastfeeding.
- Previous participants in a laboratory stress protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lauren J Owen, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Beckett University
Leeds, West Yorkshire, LS1 3HE
Zoe K Kolokotroni, PhD, 01138123271, z.kolokotroni@leedsbeckett.ac.uk
Lauren J Owen, PhD, l.j.owen@leedsbeckett.ac.uk
About this study
Official title: A Double-blind, Placebo-controlled, Randomised, Acute, Repeated Measures Cross-over Study to Evaluate the Impact of Skoshify 'Think Tank' Nutritional Formulation on Cognitive Performance Following Stress Exposure.
The proposed project will evaluate the synergistic effects of a nutritional formulation, 'Think Tank' on cognitive performance following exposure to a psychological and physical stressor. Adopting a double-blind repeated measures cross-over design, middle-aged females (40-60 years) will be recruited to take part in a two-stage research study that will examine whether the formulation enhances cognitive performance and subjective well-being following the challenge of a stressor, compared to placebo. Cognitive assessments will examine the impact of the nutritional formulation on working memory, sustained attention, cognitive flexibility and inhibitory control. The study will also assess physiological (heart rate, blood pressure and cortisol) and subjective (well-being, anxiety, positive and negative mood, stress) markers of stress reactivity. The study will also explore levels sleep quality, mental and physical fatigue, effort, productivity, and perceived impact of the intervention.
Read the detailed description
Chronic stress can have a profound impact on quality of life, including cognitive health. Nutritional interventions offer promising, non-pharmacological approaches to support brain health, with particular nutrients showing potential to modulate stress and cognitive function. Creatine, Magnesium, L-Tyrosine, L-Theanine, Rhodiola, Phosphatidylserine and Citicoline have been shown to independently offer cognitive benefits, with the greatest impact observed during episodes of physiological and psychological stress. It is currently unknown whether a combination of these nutrients could produce a synergistic effect on cognitive performance that exceeds the impact of the individual nutrients alone.
This study will follow a double-blind, placebo-controlled, randomised, acute, repeated measures cross-over study design examining cognitive performance, productivity, sleep quality, mental and physical fatigue and subjective/physiological/endocrine responses to an acute psychological and physical stressor following (i) 'nutritional formulation+caffeine' or (ii) 'placebo+caffeine' drink. This research has the potential to identify a novel nutritional intervention that can reduce the negative impacts of stress on cognition.
Participants interested in the study will first take part in an initial health screening to ensure all criteria for eligibility are met. The health screening will include questions on physical and psychological conditions, medication, menstrual cycle, dietary behaviours and supplementation use. Eligible participants will then attend the Human Behavioural Neuroscience Labs at Leeds Beckett University city campus on three occasions over a period of a maximum of 8 weeks.
Prior to all visits participants will be asked to abstain from alcohol and exercise for 24 hours and to fast one hour prior to the session. Participants will also be asked to abstain from caffeine use for a minimum of 6 hours prior to the session. The first visit will involve collection of demographic information and completion of stress, anxiety and depression scales. Daily intake of caffeine consumption and dependency, levels of sleep quality will also be measured. Height and weight will be measured and baseline blood pressure readings taken. Familiarisation with the cognitive tasks will also take place during this visit. Participants will complete the CANTAB battery cognitive tasks to reduce the impact of early practice effects during the test session assessment. Following familiarisation, baseline cognitive performance will also assessed. The CANTAB battery will include the Digit Span (assessment of working memory and attention), Intra-Extra Dimensional Set Shift ( assessment of cognitive shifting and flexibility), Stop-Signal Task (assessment of executive function and inhibitory control) and Rapid Visual Information Processing (assessment of sustained attention).
Experimental test sessions two and three will follow identical procedures. Following a 15-minute resting period, baseline cortisol saliva sample, cardiovascular measures (heart rate and blood pressure), mood state, will be taken. The intervention will then be administered (Formulation + Caffeine) or (Placebo + Caffeine) in 200ml drink and consumed within a 5-minute timeframe. Following a 30 minute absorption period, participants will then be taken to a separate stress-induction room where they will be introduced to the Trier Social Stress Test (TSST). Following completion of the TSST, participants will then complete the Socially evaluated cold pressor test (SECPT). A combination of both the TSST and SCEPT will ensure activation of the both the autonomic and glucocorticoid stress systems and reduce the level of habituation to the stress response across repeated test sessions. The stress protocol will last approximately 20 minutes.
Following stress exposure, the CANTAB battery of cognitive tests will be administered in a serial order. Cognitive assessment will take place during the 40-minute period post-stressor. Throughout the test session cortisol saliva samples, cardiovascular measures (heart rate and blood pressure), mood state, levels of fatigue and perceptions of intervention impact will be measured. Twenty-four hours post session, an online questionnaire assessing the previous night's sleep and levels of productivity since treatment consumption will be administered. Data on side effects and physical experiences following treatment/placebo consumption will also be collected at this time point.
- Conditions
- Cognitive Assessment, Working Memory, Executive Function (Cognition), Sustained Attention, Inhibitory Control, Cognitive Flexibility
- Being tested
- Skoshify 'Think Tank' Formulation, Placebo
- Keywords
- Cognitive Performance, Stress Response, Creatine, Magnesium, L-Tyrosine, L-Theanine, Rhodiola, Phosphatidylserine, Citicoline
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders, Mental Fatigue, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skoshify 'Think Tank' FormulationDietary supplement
Each acute dose contains, Magnesium 105mg, Sodium 5mg, Creatine Monohydrate 2.5g, Magnesium Gluconate 2g, L-Tyrosine 500mg, Phosphatidylserine 20% powder 200mg, L-Theanine 200mg, Citicoline Sodium 125mg, Rhodiola Rosea Root Extract 100mg.
PlaceboOther
The placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g.
| Study group | Role | What they receive |
|---|---|---|
| Single acute dose (5.6g) of 'Think Tank' Formulation in a caffeine vehicle. | Active comparator | The active formulation will be dissolved in a 200ml volume coffee beverage (1.8g Nescafe, 50-100mg caffeine). The coffee beverage will be brewed at approximately 90-96◦C. When the beverage has reached a temperature of 65◦C the active nutritional formulation will be added and mixed until dissolved. Each acute dose contains, Magnesium 105mg, Sodium 5mg, Creatine Monohydrate 2.5g, Magnesium Gluconate 2g, L-Tyrosine 500mg, Phosphatidylserine 20% powder 200mg, L-Theanine 200mg, Citicoline Sodium 125mg, Rhodiola Rosea Root Extract 100mg. Receives: Dietary Supplement: Skoshify 'Think Tank' Formulation |
| Single acute dose (2.0g) of matched placebo in a caffeine vehicle. | Placebo comparator | The placebo will be dissolved in a 200ml volume coffee beverage (1.8g Nescafe, 50-100mg caffeine). The coffee beverage will be brewed at approximately 90-96◦C. When the beverage has reached a temperature of 65◦C the placebo will be added and mixed until dissolved. The placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory Performance
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Digit Span Task (Forwards and Backwards). The task measures verbal short term working memory. Participants hear a series of digits and are asked to then immediately verbally repeat the sequence, either as it was heard (forwards), or in reverse order (backwards). The forwards tasks assesses verbal working memory and attention, while the backwards span task additionally tests cognitive control and executive function. The primary outcome is the longest sequence problem successfully reached and passed by the subject scored 0 to 9, with a higher score indicating better performance. The total number of attempts made by a subject across all spans reached is also measured, scored 0 to 18, with a lower score indicating better performance.
Measured: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2).
Cognitive flexibility and attentional set-shifting.
Assessed using the Cambridge Neuropsychological Test Automated Battery Intra-Extra Dimensional Set-Shift Task. The task assesses the ability to shift attention between different stimulus dimensions and adapt to changing rules. The outcome measure is the total number of times that the subject chose a wrong stimulus, measured from 0 to 402, and the total number of trials for which the outcome was an incorrect response, measured from 0 to 50. Lower scores indicate better performance.
Measured: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2)
Sustained attention.
Assessed using the Cambridge Neuropsychological Test Automated Battery Rapid Visual Information Processing Task. Participants are presented with digits 2-9 in a pseudo-random order and are requested to detect three -target sequences of digits (e.g. 4-6-8). The primary outcomes are, 'A' the signal detection measure of a subject's sensitivity to the target sequence, scored from 0 to 1 , with higher scores indicating better performance. The RVP Probability of False Alarm, scored 0 to 1 is also measured, with lowers scores indicating a better performance. Median response latency on trials where the subject responded correctly is also calculated.
Measured: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2)
Inhibitory control
Assessed using the Cambridge Neuropsychological Test Automated Battery Stop-Signal Task. The task measures the ability to inhibit a pre-planned, dominant motor response. The main outcome is the Stop Signal Reaction Time, the estimate of time where an individual can successfully inhibit their responses 50% of the time, measured from 0 to 1000, with lower scores indicating better inhibitory control.
Measured: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2)
Secondary outcomes (9)
Salivary cortisol
Saliva will be collected via saliva collection aids to assess HPA activity.
Measured: Saliva will be collected across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). During each timepoint, a total of 6 samples will be taken during the test session.
Blood pressure
Blood pressure will be measured using an ambulatory blood pressure monitor. The blood pressure cuff will be placed on the upper non-dominant arm.
Measured: Blood pressure will be measured across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). During each timepoint, a total of 8 blood pressure readings will be taken across the test session.
Heart rate
Heart rate will be measured using the H10 Polar heart rate monitor.
Measured: Heart rate will be measured across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). During each timepoint, a total of 8 heart rate epochs readings will be taken across the test session.
Positive and Negative Affect Scale (PANAS)
A 20 item scale assessing two dimensions of positive and negative affect on a 4-point Likert scale from Very slightly/Not at all to Extremely. Scores on each dimension can range from 10 - 50, with higher scores representing higher levels of positive and negative affect.
Measured: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 4 times within the test session, and once four hours post session.
Visual Analogue Scale (VAS)
A self-devised brief 100mm visual analogue scale assessing dimensions of happiness, sadness, tiredness, anxiety, stress, withdrawal, pain, mental fatigue, physical fatigue, level of focus and effort. Scores range from 0 -100, with higher scores indicating greater levels of each dimension.
Measured: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 7 times within the test session, and once four hours post session.
Felt Effect Scale
A 6 item VAS assessing perception of intervention impact, measuring items on a 0-100 scale, with higher scores indicating a greater impact.
Measured: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 3 times within the test session at 30, 53, ad 95 mins post intervention, and once four hours post session.
Leeds Sleep Evaluation Questionnaire
a 10-item VAS scale designed to measure changes in subjective sleep quality across areas of getting to sleep, quality of sleep, ease of waking, and early morning behaviour following wakening. Scores range from 0 to 100, with higher scores indicating better sleep quality.
Measured: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 2 times, once at the beginning of the test session, and once 24 hours post session.
Productivity Scale
A 5 -item self-devised productivity scale will assess productivity, focus, and mental alertness. Levels of productivity will be assessed via a 0-100 scale, with higher scores indicating greater levels of productivity.
Measured: Assessed across 2 timepoints (once in each Arm). Assessed once 24 hours post Visit Two (Test session 1) and Visit Three (Test session 2).
Health Events and Physical Experiences
Participants will be asked to report if they experienced any adverse symptoms in the 24 hours following the test-session, including gastrointestinal symptoms, headaches, dizziness, light-headedness, and mood changes. Participants will be asked to report on the presence and severity of these symptoms.
Measured: Assessed across 2 timepoints (once in each Arm). Assessed 24 hours post Visit Two (Test session 1) and Visit Three (Test session 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive AssessmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will follow a double-blind, placebo-controlled, randomised, acute, repeated measures cross-over study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Collaborators
- Sköshify™ Corporate HQ, 7045 Quiet Retreat Court, Niwot, CO 80503-7174
- Responsible party
- Principal investigator, Zoe Kolokotroni, Leeds Beckett University
- Investigators
- Zoe K Kolokotroni, PhD, Principal investigator, Leeds Beckett University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319117
- Sponsor's protocol ID
- P34232
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to data compliance/ethical restrictions.
Publications
Dassanayake TL, Wijesundara D, Kahathuduwa CN, Weerasinghe VS. Dose-response effect of L-theanine on psychomotor speed, sustained attention, and inhibitory control: a double-blind, placebo-controlled, crossover study. Nutr Neurosci. 2023 Nov;26(11):1138-1146. doi: 10.1080/1028415X.2022.2136884. Epub 2022 Oct 20.
PubMed 36263942Baba Y, Inagaki S, Nakagawa S, Kaneko T, Kobayashi M, Takihara T. Effects of l-Theanine on Cognitive Function in Middle-Aged and Older Subjects: A Randomized Placebo-Controlled Study. J Med Food. 2021 Apr;24(4):333-341. doi: 10.1089/jmf.2020.4803. Epub 2021 Mar 22.
PubMed 33751906Magill RA, Waters WF, Bray GA, Volaufova J, Smith SR, Lieberman HR, McNevin N, Ryan DH. Effects of tyrosine, phentermine, caffeine D-amphetamine, and placebo on cognitive and motor performance deficits during sleep deprivation. Nutr Neurosci. 2003 Aug;6(4):237-46. doi: 10.1080/1028415031000120552.
PubMed 12887140Alvarez XA, Laredo M, Corzo D, Fernandez-Novoa L, Mouzo R, Perea JE, Daniele D, Cacabelos R. Citicoline improves memory performance in elderly subjects. Methods Find Exp Clin Pharmacol. 1997 Apr;19(3):201-10.
PubMed 9203170Jongkees BJ, Hommel B, Kuhn S, Colzato LS. Effect of tyrosine supplementation on clinical and healthy populations under stress or cognitive demands--A review. J Psychiatr Res. 2015 Nov;70:50-7. doi: 10.1016/j.jpsychires.2015.08.014. Epub 2015 Aug 25.
PubMed 26424423
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomised, Acute, Repeated Measures Cross-over Study to Evaluate the Impact of Skoshify 'Think Tank' Nutritional Formulation on Cognitive Performance Following Stress Exposure.
- ClinicalTrials.gov ID
- NCT07319117
- Acronym / sponsor ID
- P34232
- Conditions
- Cognitive Assessment, Working Memory, Executive Function (Cognition), Sustained Attention, Inhibitory Control, Cognitive Flexibility
- Keywords
- Cognitive Performance, Stress Response, Creatine, Magnesium, L-Tyrosine, L-Theanine, Rhodiola, Phosphatidylserine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Collaborators
- Sköshify™ Corporate HQ, 7045 Quiet Retreat Court, Niwot, CO 80503-7174
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- 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.
The proposed project will evaluate the synergistic effects of a nutritional formulation, 'Think Tank' on cognitive performance following exposure to a psychological and physical stressor. Adopting a double-blind repeated measures cross-over design, middle-aged females (40-60 years) will be recruited to take part in a two-stage research study that will examine whether the formulation enhances cognitive performance and subjective well-being following the challenge of a stressor, compared to placebo. Cognitive assessments will examine the impact of the nutritional formulation on working memory, sustained attention, cognitive flexibility and inhibitory control. The study will also assess physiological (heart rate, blood pressure and cortisol) and subjective (well-being, anxiety, positive and negative mood, stress) markers of stress reactivity. The study will also explore levels sleep quality, mental and physical fatigue, effort, productivity, and perceived impact of the intervention.
Detailed description
Chronic stress can have a profound impact on quality of life, including cognitive health. Nutritional interventions offer promising, non-pharmacological approaches to support brain health, with particular nutrients showing potential to modulate stress and cognitive function. Creatine, Magnesium, L-Tyrosine, L-Theanine, Rhodiola, Phosphatidylserine and Citicoline have been shown to independently offer cognitive benefits, with the greatest impact observed during episodes of physiological and psychological stress. It is currently unknown whether a combination of these nutrients could produce a synergistic effect on cognitive performance that exceeds the impact of the individual nutrients alone.
This study will follow a double-blind, placebo-controlled, randomised, acute, repeated measures cross-over study design examining cognitive performance, productivity, sleep quality, mental and physical fatigue and subjective/physiological/endocrine responses to an acute psychological and physical stressor following (i) 'nutritional formulation+caffeine' or (ii) 'placebo+caffeine' drink. This research has the potential to identify a novel nutritional intervention that can reduce the negative impacts of stress on cognition.
Participants interested in the study will first take part in an initial health screening to ensure all criteria for eligibility are met. The health screening will include questions on physical and psychological conditions, medication, menstrual cycle, dietary behaviours and supplementation use. Eligible participants will then attend the Human Behavioural Neuroscience Labs at Leeds Beckett University city campus on three occasions over a period of a maximum of 8 weeks.
Prior to all visits participants will be asked to abstain from alcohol and exercise for 24 hours and to fast one hour prior to the session. Participants will also be asked to abstain from caffeine use for a minimum of 6 hours prior to the session. The first visit will involve collection of demographic information and completion of stress, anxiety and depression scales. Daily intake of caffeine consumption and dependency, levels of sleep quality will also be measured. Height and weight will be measured and baseline blood pressure readings taken. Familiarisation with the cognitive tasks will also take place during this visit. Participants will complete the CANTAB battery cognitive tasks to reduce the impact of early practice effects during the test session assessment. Following familiarisation, baseline cognitive performance will also assessed. The CANTAB battery will include the Digit Span (assessment of working memory and attention), Intra-Extra Dimensional Set Shift ( assessment of cognitive shifting and flexibility), Stop-Signal Task (assessment of executive function and inhibitory control) and Rapid Visual Information Processing (assessment of sustained attention).
Experimental test sessions two and three will follow identical procedures. Following a 15-minute resting period, baseline cortisol saliva sample, cardiovascular measures (heart rate and blood pressure), mood state, will be taken. The intervention will then be administered (Formulation + Caffeine) or (Placebo + Caffeine) in 200ml drink and consumed within a 5-minute timeframe. Following a 30 minute absorption period, participants will then be taken to a separate stress-induction room where they will be introduced to the Trier Social Stress Test (TSST). Following completion of the TSST, participants will then complete the Socially evaluated cold pressor test (SECPT). A combination of both the TSST and SCEPT will ensure activation of the both the autonomic and glucocorticoid stress systems and reduce the level of habituation to the stress response across repeated test sessions. The stress protocol will last approximately 20 minutes.
Following stress exposure, the CANTAB battery of cognitive tests will be administered in a serial order. Cognitive assessment will take place during the 40-minute period post-stressor. Throughout the test session cortisol saliva samples, cardiovascular measures (heart rate and blood pressure), mood state, levels of fatigue and perceptions of intervention impact will be measured. Twenty-four hours post session, an online questionnaire assessing the previous night's sleep and levels of productivity since treatment consumption will be administered. Data on side effects and physical experiences following treatment/placebo consumption will also be collected at this time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will follow a double-blind, placebo-controlled, randomised, acute, repeated measures cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Single acute dose (5.6g) of 'Think Tank' Formulation in a caffeine vehicle. | Active comparator | Dietary Supplement: Skoshify 'Think Tank' FormulationThe active formulation will be dissolved in a 200ml volume coffee beverage (1.8g Nescafe, 50-100mg caffeine). The coffee beverage will be brewed at approximately 90-96◦C. When the beverage has reached a temperature of 65◦C the active nutritional formulation will be added and mixed until dissolved. Each acute dose contains, Magnesium 105mg, Sodium 5mg, Creatine Monohydrate 2.5g, Magnesium Gluconate 2g, L-Tyrosine 500mg, Phosphatidylserine 20% powder 200mg, L-Theanine 200mg, Citicoline Sodium 125mg, Rhodiola Rosea Root Extract 100mg. |
| Single acute dose (2.0g) of matched placebo in a caffeine vehicle. | Placebo comparator | Other: PlaceboThe placebo will be dissolved in a 200ml volume coffee beverage (1.8g Nescafe, 50-100mg caffeine). The coffee beverage will be brewed at approximately 90-96◦C. When the beverage has reached a temperature of 65◦C the placebo will be added and mixed until dissolved. The placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to provide written informed consent (in English)
- Aged 40-60
- Female
- Daily caffeine drinkers
- Healthy and free from significant physical and psychiatric disorders
Key exclusion criteria (14 listed)
- Current cigarette smokers/vapers.
- Known food allergy or intolerance to the investigational products or control products.
- Not willing to consume coffee.
- Individuals diagnosed with psychiatric/mental health conditions.
- Individuals engaging in recreational drug use.
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 |
|---|---|---|
| Skoshify 'Think Tank' FormulationEach acute dose contains, Magnesium 105mg, Sodium 5mg, Creatine Monohydrate 2.5g, Magnesium Gluconate 2g, L-Tyrosine 500mg, Phosphatidylserine 20% powder 200mg, L-Theanine 200mg, Citicoline Sodium 125mg, Rhodiola Rosea Root Extract 100mg. | Dietary supplement | Single acute dose (5.6g) of 'Think Tank' Formulation in a caffeine vehicle. |
| PlaceboThe placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g. | Other | Single acute dose (2.0g) of matched placebo in a caffeine vehicle. |
Primary outcome
Working Memory Performance
Time frame: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2).
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Digit Span Task (Forwards and Backwards). The task measures verbal short term working memory. Participants hear a series of digits and are asked to then immediately verbally repeat the sequence, either as it was heard (forwards), or in reverse order (backwards). The forwards tasks assesses verbal working memory and attention, while the backwards span task additionally tests cognitive control and executive function. The primary outcome is the longest sequence problem successfully reached and passed by the subject scored 0 to 9, with a higher score indicating better performance. The total number of attempts made by a subject across all spans reached is also measured, scored 0 to 18, with a lower score indicating better performance.
Cognitive flexibility and attentional set-shifting.
Time frame: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2)
Assessed using the Cambridge Neuropsychological Test Automated Battery Intra-Extra Dimensional Set-Shift Task. The task assesses the ability to shift attention between different stimulus dimensions and adapt to changing rules. The outcome measure is the total number of times that the subject chose a wrong stimulus, measured from 0 to 402, and the total number of trials for which the outcome was an incorrect response, measured from 0 to 50. Lower scores indicate better performance.
Sustained attention.
Time frame: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2)
Assessed using the Cambridge Neuropsychological Test Automated Battery Rapid Visual Information Processing Task. Participants are presented with digits 2-9 in a pseudo-random order and are requested to detect three -target sequences of digits (e.g. 4-6-8). The primary outcomes are, 'A' the signal detection measure of a subject's sensitivity to the target sequence, scored from 0 to 1 , with higher scores indicating better performance. The RVP Probability of False Alarm, scored 0 to 1 is also measured, with lowers scores indicating a better performance. Median response latency on trials where the subject responded correctly is also calculated.
Inhibitory control
Time frame: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2)
Assessed using the Cambridge Neuropsychological Test Automated Battery Stop-Signal Task. The task measures the ability to inhibit a pre-planned, dominant motor response. The main outcome is the Stop Signal Reaction Time, the estimate of time where an individual can successfully inhibit their responses 50% of the time, measured from 0 to 1000, with lower scores indicating better inhibitory control.
9 secondary outcomes
Salivary cortisol
Time frame: Saliva will be collected across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). During each timepoint, a total of 6 samples will be taken during the test session.
Blood pressure
Time frame: Blood pressure will be measured across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). During each timepoint, a total of 8 blood pressure readings will be taken across the test session.
Heart rate
Time frame: Heart rate will be measured across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). During each timepoint, a total of 8 heart rate epochs readings will be taken across the test session.
Positive and Negative Affect Scale (PANAS)
Time frame: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 4 times within the test session, and once four hours post session.
Visual Analogue Scale (VAS)
Time frame: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 7 times within the test session, and once four hours post session.
Felt Effect Scale
Time frame: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 3 times within the test session at 30, 53, ad 95 mins post intervention, and once four hours post session.
Leeds Sleep Evaluation Questionnaire
Time frame: Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 2 times, once at the beginning of the test session, and once 24 hours post session.
Productivity Scale
Time frame: Assessed across 2 timepoints (once in each Arm). Assessed once 24 hours post Visit Two (Test session 1) and Visit Three (Test session 2).
Health Events and Physical Experiences
Time frame: Assessed across 2 timepoints (once in each Arm). Assessed 24 hours post Visit Two (Test session 1) and Visit Three (Test session 2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 36263942Dassanayake TL, Wijesundara D, Kahathuduwa CN, Weerasinghe VS. Dose-response effect of L-theanine on psychomotor speed, sustained attention, and inhibitory control: a double-blind, placebo-controlled, crossover study. Nutr Neurosci. 2023 Nov;26(11):1138-1146. doi: 10.1080/1028415X.2022.2136884. Epub 2022 Oct 20.
- Background: PubMed 33751906Baba Y, Inagaki S, Nakagawa S, Kaneko T, Kobayashi M, Takihara T. Effects of l-Theanine on Cognitive Function in Middle-Aged and Older Subjects: A Randomized Placebo-Controlled Study. J Med Food. 2021 Apr;24(4):333-341. doi: 10.1089/jmf.2020.4803. Epub 2021 Mar 22.
- Background: PubMed 12887140Magill RA, Waters WF, Bray GA, Volaufova J, Smith SR, Lieberman HR, McNevin N, Ryan DH. Effects of tyrosine, phentermine, caffeine D-amphetamine, and placebo on cognitive and motor performance deficits during sleep deprivation. Nutr Neurosci. 2003 Aug;6(4):237-46. doi: 10.1080/1028415031000120552.
- Background: PubMed 9203170Alvarez XA, Laredo M, Corzo D, Fernandez-Novoa L, Mouzo R, Perea JE, Daniele D, Cacabelos R. Citicoline improves memory performance in elderly subjects. Methods Find Exp Clin Pharmacol. 1997 Apr;19(3):201-10.
- Background: PubMed 26424423Jongkees BJ, Hommel B, Kuhn S, Colzato LS. Effect of tyrosine supplementation on clinical and healthy populations under stress or cognitive demands--A review. J Psychiatr Res. 2015 Nov;70:50-7. doi: 10.1016/j.jpsychires.2015.08.014. Epub 2015 Aug 25.
- Individual participant dataSharing planned: Undecided. Due to data compliance/ethical restrictions.
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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.
Lauren J Owen, PhD contact
Zoe K Kolokotroni, PhD principal investigator
Leeds Beckett 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 Skoshify 'Think Tank' Formulation in people with Cognitive Assessment and Working Memory, run by Leeds Beckett University at 1 site in United Kingdom.
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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe K Kolokotroni, PhD (+441138123271, z.kolokotroni@leedsbeckett.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Memory Performance (time frame: Assessed across 3 timepoints. At baseline (Visit one - Screening) and immediately post stress exposure following consumption of either the active formulation (Visit Two - Test session 1) or placebo (Visit Three - Test session 2).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07319117, which also lists 5 linked publications.
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 6 Jan 2026.