Evaluation of the Impact of a Nutritional Formulation on Cognitive Performance Following Stress Exposure.
Recruiting · NCT07319117 · Interventional (participants receive a specific treatment) · Lead sponsor: Leeds Beckett University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Leeds Beckett University - Leeds, West Yorkshire, United Kingdom