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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Working Memory Performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent (in English)
- •Daily caffeine drinkers
- •Healthy and free from significant physical and psychiatric disorders
排除标准
- •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.
结局指标
主要结局
Working Memory Performance
时间窗: 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).
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.
时间窗: 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)
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.
时间窗: 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)
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
时间窗: 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)
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.
次要结局
- 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.)
- Felt Effect Scale(Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 3 times within the test session at 30, 53, ad 95 mins post intervention, and once four hours post session.)
- Leeds Sleep Evaluation Questionnaire(Assessed across 2 timepoints, during Visit Two (Test session 1) and Visit Three (Test session 2). At each timepoint the measure will be completed 2 times, once at the beginning of the test session, and once 24 hours post session.)
- Productivity Scale(Assessed across 2 timepoints (once in each Arm). Assessed once 24 hours post Visit Two (Test session 1) and Visit Three (Test session 2).)
- Health Events and Physical Experiences(Assessed across 2 timepoints (once in each Arm). Assessed 24 hours post Visit Two (Test session 1) and Visit Three (Test session 2).)
研究者
Zoe Kolokotroni
Principal Investigator
Leeds Beckett University