RecruitingNot ApplicableNCT07319117

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

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.


Sponsor

Leeds Beckett University

Enrollment

40 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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

Exclusion Criteria14

  • 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.

Interventions

DIETARY_SUPPLEMENTSkoshify '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.

OTHERPlacebo

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


Locations(1)

Leeds Beckett University

Leeds, West Yorkshire, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07319117


Related Trials