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

NCT07319117 | Recruiting

• 1 other identifier: P34232
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cognitive Performance; Stress Response; Creatine; Magnesium; L-Tyrosine; L-Theanine; Rhodiola; Phosphatidylserine; Citicoline

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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 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 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 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)

  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)

  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.

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Skoshify 'Think Tank' Formulation 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 (5.6g) of 'Think Tank' Formulation in a caffeine vehicle.

Placebo OTHER

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

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

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Leeds Beckett University: lead
• Sköshify™ Corporate HQ, 7045 Quiet Retreat Court, Niwot, CO 80503-7174: collaborator

Study Sites (1)

Leeds Beckett University

Leeds, West Yorkshire, LS1 3HE, United Kingdom

RECRUITING

Related Publications (5)

• 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.

  PMID: 36263942 BACKGROUND

• 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.

  PMID: 33751906 BACKGROUND

• 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.

  PMID: 12887140 BACKGROUND

• 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.

  PMID: 9203170 BACKGROUND

• 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.

  PMID: 26424423 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Mental Fatigue; Fractures, Stress

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Study Officials

• Zoe K Kolokotroni, PhD

  Leeds Beckett University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe K Kolokotroni, PhD

CONTACT

+441138123271; z.kolokotroni@leedsbeckett.ac.uk

Lauren J Owen, PhD

CONTACT

l.j.owen@leedsbeckett.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will follow a double-blind, placebo-controlled, randomised, acute, repeated measures cross-over study. Blinding will be maintained for investigators administering the intervention and analysing outcomes. Participants will receive a matched placebo, or active formulation drink matched in appearance, taste and volume. The placebo and active formulations will be administered in a caffeine vehicle.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will follow a double-blind, placebo-controlled, randomised, acute, repeated measures cross-over study.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 6, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

GB (1)