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Evaluation of the Impact of a Nutritional Formulation on Cognitive Performance Following Stress Exposure.

Sponsor: Leeds Beckett University

NCT ID: NCT07319117

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Skoshify 'Think Tank' Formulation (supplement), Placebo (other)
How long the study runs
Study runs about 8 months (dates as stated)
About the drug or intervention
Skoshify 'Think Tank' Formulation — 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. · Placebo — other: The placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 60 Years
Who
Female
Number of participants
40
Started
2025-12-15
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for cognitive assessment
  • • NA - 40 participants
  • • 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

Who can take part?

  • • Ages 40 Years to 60 Years
  • • Diagnosed with cognitive assessment
  • • Female only

Where?

  • • Leeds - Leeds Beckett University

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Cognitive AssessmentWorking MemoryExecutive Function (Cognition)Sustained AttentionInhibitory ControlCognitive FlexibilityCortisolStressAnxietyDepressionSleep QualityBlood PressureHeart RateMental FatiguePhysical FatigueProductivityEffort

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 60 Years
  • Who can join: Female only

What the study is looking for

  • ✓Willing and able to provide written agreement to take part (in English)
  • ✓Aged 40-60
  • ✓Female
  • ✓Daily caffeine drinkers
  • ✓Healthy and free from significant physical and psychiatric disorders

Who cannot take part

  • ✗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.
See the full criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent (in English) 2. Aged 40-60 3. Female 4. Daily caffeine drinkers 5. Healthy and free from significant physical and psychiatric disorders Exclusion Criteria: 1. Current cigarette smokers/vapers. 2. Known food allergy or intolerance to the investigational products or control products. 3. Not willing to consume coffee. 4. Individuals diagnosed with psychiatric/mental health conditions. 5. Individuals engaging in recreational drug use. 6. Individuals with diagnosed cardiovascular conditions (e.g. heart disease, high blood pressure) 7. Individuals taking prescribed medication except contraceptives/hormone replacement therapy 8. Individuals suffering from Raynaud's or circulatory issues 9. Individuals who have suffered an injury or infection in their hand/arm in the last month 10. Individuals who have suffered from chronic pain conditions or experience extreme numbness or pain in response to cold temperatures. 11. Previous brain injury/brain surgery 12. Individuals who work night shifts. 13. Currently pregnant or breastfeeding. 14. Previous participants in a laboratory stress protocol.

Where Is This Study? (1 UK site)

Leeds Beckett University

Leeds LS1 3HE, United Kingdom

Recruiting
Site contact (verified)
Zoe K Kolokotroni, PhDPrincipal Investigator
Lauren J Owen, PhDl.j.owen@leedsbeckett.ac.uk

How to Get in Touch

Zoe K Kolokotroni, PhD

Sponsor contact

CONTACT

+441138123271 z.kolokotroni@leedsbeckett.ac.uk

Lauren J Owen, PhD

Sponsor contact

CONTACT

l.j.owen@leedsbeckett.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-12