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

NCT ID: NCT07319117

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-08-31

Brief 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. 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.

Conditions

Cognitive Assessment; Working Memory; Executive Function (Cognition); Sustained Attention; Inhibitory Control; Cognitive Flexibility; Cortisol; Stress; Anxiety; Depression; Sleep Quality; Blood Pressure; Heart Rate; Mental Fatigue; Physical Fatigue; Productivity; Effort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single acute dose (5.6g) of 'Think Tank' Formulation in a caffeine vehicle.

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.

Group Type: ACTIVE_COMPARATOR

Skoshify 'Think Tank' Formulation

Intervention Type: DIETARY_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.

Single acute dose (2.0g) of matched placebo in a caffeine vehicle.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g.

Interventions

Skoshify 'Think Tank' Formulation

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sköshify™ Corporate HQ, 7045 Quiet Retreat Court, Niwot, CO 80503-7174

UNKNOWN

Sponsor Role: collaborator

Leeds Beckett University

OTHER

Sponsor Role: lead

Responsible Party

Zoe Kolokotroni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zoe K Kolokotroni, PhD

Role: PRINCIPAL_INVESTIGATOR

Leeds Beckett University

Locations

Leeds Beckett University

Leeds, West Yorkshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Zoe K Kolokotroni, PhD

Role: CONTACT

z.kolokotroni@leedsbeckett.ac.uk

+441138123271

Lauren J Owen, PhD

Role: CONTACT

l.j.owen@leedsbeckett.ac.uk

Facility Contacts

Zoe K Kolokotroni, PhD

Role: primary

z.kolokotroni@leedsbeckett.ac.uk

01138123271

Lauren J Owen, PhD

Role: backup

l.j.owen@leedsbeckett.ac.uk

References

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.

Reference Type: BACKGROUND

PMID: 36263942 (View on PubMed)

Baba 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.

Reference Type: BACKGROUND

PMID: 33751906 (View on PubMed)

Magill 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.

Reference Type: BACKGROUND

PMID: 12887140 (View on PubMed)

Alvarez 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.

Reference Type: BACKGROUND

PMID: 9203170 (View on PubMed)

Jongkees 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.

Reference Type: BACKGROUND

PMID: 26424423 (View on PubMed)

Other Identifiers

P34232

Identifier Type: -

Identifier Source: org_study_id