NCT07319117 Evaluation of the Impact of a Nutritional Formulation on Cognitive Performance Following Stress Exposure.
| NCT ID | NCT07319117 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leeds Beckett University |
| Condition | Cognitive Assessment |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-12-15 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent (in English) 2. Aged 40-60 3. Female 4. Daily caffeine drinkers 5. Healthy and free from significant physical and psychiatric disorders Exclusion Criteria: 1. Current cigarette smokers/vapers. 2. Known food allergy or intolerance to the investigational products or control products. 3. Not willing to consume coffee. 4. Individuals diagnosed with psychiatric/mental health conditions. 5. Individuals engaging in recreational drug use. 6. Individuals with diagnosed cardiovascular conditions (e.g. heart disease, high blood pressure) 7. Individuals taking prescribed medication except contraceptives/hormone replacement therapy 8. Individuals suffering from Raynaud's or circulatory issues 9. Individuals who have suffered an injury or infection in their hand/arm in the last month 10. Individuals who have suffered from chronic pain conditions or experience extreme numbness or pain in response to cold temperatures. 11. Previous brain injury/brain surgery 12. Individuals who work night shifts. 13. Currently pregnant or breastfeeding. 14. Previous participants in a laboratory stress protocol.
Contact & Investigator
Zoe K Kolokotroni, PhD
PRINCIPAL INVESTIGATOR
Leeds Beckett University
Frequently Asked Questions
Who can join the NCT07319117 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 60 Years, studying Cognitive Assessment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07319117 currently recruiting?
Yes, NCT07319117 is actively recruiting participants. Contact the research team at z.kolokotroni@leedsbeckett.ac.uk for enrollment information.
Where is the NCT07319117 trial being conducted?
This trial is being conducted at Leeds, United Kingdom.
Who is sponsoring the NCT07319117 clinical trial?
NCT07319117 is sponsored by Leeds Beckett University. The principal investigator is Zoe K Kolokotroni, PhD at Leeds Beckett University. The trial plans to enroll 40 participants.