Cognitive Performance (Focus) Clinical Trial
Official title:
A Randomised, Double-blind, Parallel Groups, Placebo-controlled 6 Weeks Human Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance
| Verified date | May 2014 |
| Source | University of Leeds |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
The study will explore the effects of a 6-week phospholipid drink intervention on the cognitive performance and physiological and subjective stress parameters of males following a repeated psychosocial/physical stressor.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | August 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Male =18 years old - Healthy (self-report health questionnaire) - BMI <30 kg/m² - Free from medication (prescribed and 'over-the-counter') Exclusion Criteria: - Current psychological affective/mood disorders - Self-reported physical disorder/disease (significant cardiovascular, autoimmune, endocrine, gastrointestinal or neurological conditions, chronic pain, or sleep disorders) - High chronic stress - Smokers - Recreational drug use (within the last month) - Night shift work - Hypertension (resting blood pressure exceeding 160/95 mmHg) - Skin conditions (e.g. eczema) on hands - Food allergies - Participation in a clinical study within a month prior to screening or during participation - Participation in any of our previous stress induction studies |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Human Appetite Research Unit, University of Leeds | Leeds | West Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Leeds | Arla Foods |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cognitive performance change from baseline | Performance on a cognitive test battery at baseline will be compared to performance at week 6 | Week 1 (baseline) and week 6 | No |
| Secondary | Salivary cortisol change from baseline | Salivettes will be used to collect salivary cortisol response across exposure to a laboratory stress protocol on two occasions separated by 6 weeks | Week 1 (baseline) and week 6 | No |
| Secondary | Blood pressure (systolic/diastolic) change from baseline | An ambulatory blood pressure monitor will be used to collect blood pressure response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks | Week 1 (baseline) and week 6 | No |
| Secondary | Heart rate change from baseline | An ambulatory blood pressure monitor will be used to collect heart rate response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks | Week 1 (baseline) and 6 weeks | No |
| Secondary | Subjective stress change from baseline | The Stress and Arousal Checklist (Mackay, 1978)will be used to collect subjective stress response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks | Week 1 (baseline) and 6 weeks | No |
| Secondary | Subjective mood change from baseline | The Profile of Mood States (Mc Nair et al., 1971)will be used to collect subjective mood response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks | Week 1 (baseline) and 6 weeks | No |