Actively Recruiting

Phase Not Applicable
Age: 40Years - 60Years
FEMALE
Healthy Volunteers
ID07319117

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

Led by Leeds Beckett University · Updated on 2026-01-06

40

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

L

Leeds Beckett University

Lead Sponsor

S

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of a nutritional drink called 'Think Tank' on cognitive performance and well-being in middle-aged women aged 40 to 60. The study focuses on how this drink may impact brain functions like memory, attention, flexibility, and control after exposure to psychological and physical stress. The study also looks at stress markers such as heart rate, blood pressure, cortisol levels, mood, sleep quality, fatigue, effort, and productivity. This is a double-blind, placebo-controlled, randomized study using a crossover design to compare the drink with a placebo in combination with caffeine. Participants will attend three visits over up to eight weeks. The first visit involves health screening, familiarization with cognitive tests, and baseline assessments. During the second and third visits, participants will consume either the active nutritional formulation or a placebo drink with caffeine, followed by a stress challenge involving social and physical stress tests. Cognitive tests and stress-related measures will be taken before and after the stress exposure. The nutritional formulation contains a blend of ingredients including magnesium, creatine, L-tyrosine, phosphatidylserine, L-theanine, citicoline, and rhodiola. Throughout the study, participants will undergo various assessments including cognitive testing with CANTAB tasks, saliva samples for cortisol, heart rate and blood pressure monitoring, mood and fatigue questionnaires, and online surveys about sleep and productivity 24 hours after each test session. Side effects and physical experiences will also be recorded. The study aims to measure working memory, cognitive flexibility, sustained attention, and inhibitory control at baseline and after stress exposure with the drink or placebo.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide written informed consent in English
  • Aged 40 to 60 years
  • Female
  • Daily caffeine drinker
  • Healthy and free from significant physical and psychiatric disorders
Not Eligible

You will not qualify if you...

  • Current cigarette smokers or vapers
  • Known allergy or intolerance to study or control products
  • Not willing to consume coffee
  • Diagnosed psychiatric or mental health conditions
  • Recreational drug use
  • Diagnosed cardiovascular conditions such as heart disease or high blood pressure
  • Taking prescribed medication except contraceptives or hormone replacement therapy
  • Suffering from Raynaud's or circulatory issues
  • Recent injury or infection in hand or arm within the last month
  • Chronic pain conditions or extreme numbness or pain from cold
  • Previous brain injury or brain surgery
  • Working night shifts
  • Currently pregnant or breastfeeding
  • Previous participants in a laboratory stress protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 8 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - Same day as screening visit

Participants complete demographic information, baseline cognitive tests, and assessments of stress, anxiety, depression, caffeine consumption, sleep quality, and physical measurements.

1 visit (in-person)

Treatment and Stress Testing Sessions

Duration - Two sessions over up to 8 weeks

Participants attend two test sessions where they consume either the nutritional formulation with caffeine or placebo with caffeine, undergo stress induction, and complete cognitive and physiological assessments.

2 visits (in-person)

Follow-up Assessments

Duration - 24 hours after each test session

Participants complete online questionnaires 24 hours after each test session to assess sleep quality, productivity, and any side effects or physical experiences.

2 online assessments

Trial Site Locations

Total: 1 location

1

Leeds Beckett University

Leeds, West Yorkshire, United Kingdom, LS1 3HE

Actively Recruiting

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Research Team

Z

Zoe K Kolokotroni, PhD

L

Lauren J Owen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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https://pubmed.ncbi.nlm.nih.gov/36263942

Effects of l-Theanine on Cognitive Function in Middle-Aged and Older Subjects: A Randomized Placebo-Controlled Study.

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Effects of tyrosine, phentermine, caffeine D-amphetamine, and placebo on cognitive and motor performance deficits during sleep deprivation.

Richard A Magill, William F Waters, George A Bray...

https://pubmed.ncbi.nlm.nih.gov/12887140

Effect of tyrosine supplementation on clinical and healthy populations under stress or cognitive demands--A review.

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