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.
Willing and able to provide written informed consent (in English)
Aged 40-60
Female
Daily caffeine drinkers
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.
Crossover
Skoshify 'Think Tank' Formulation
Dietary supplementEach 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 interventionThe placebo contains Maltodextrin from corn 1.5mg and Organic acacia gum powder 0.5g.
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.
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.
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.
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.
Salivary cortisol
Saliva will be collected via saliva collection aids to assess HPA activity.
Blood pressure
Blood pressure will be measured using an ambulatory blood pressure monitor. The blood pressure cuff will be placed on the upper non-dominant arm.
Heart rate
Heart rate will be measured using the H10 Polar heart rate monitor.
Positive and Negative Affect Scale (PANAS)
A 20 item scale assessing two dimensions of positive and negative affect on a 4-point Likert scale from Very slightly/Not at all to Extremely. Scores on each dimension can range from 10 - 50, with higher scores representing higher levels of positive and negative affect.
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Leeds Beckett University
Lead sponsor
Sköshify™ Corporate HQ, 7045 Quiet Retreat Court, Niwot, CO 80503-7174
Collaborator
