The Effect of a Phospholipid Drink on Cognitive Performance Under Acute Stress
- Conditions
- Cognitive Performance (Focus)
- Registration Number
- NCT01879813
- Lead Sponsor
- University of Leeds
- Brief Summary
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.
- Detailed Description
The study conforms to a randomised, double-blind, placebo controlled, parallel groups design examining cognitive performance and physiological/subjective stress responses after a psychosocial/physical stressor before and after a six week daily intake of an phospholipid containing drink vs. placebo.
The study will examine:
Cognitive performance following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue.
Physiological and subjective stress responses following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
- Male ≥18 years old
- Healthy (self-report health questionnaire)
- BMI <30 kg/m²
- Free from medication (prescribed and 'over-the-counter')
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cognitive performance change from baseline Week 1 (baseline) and week 6 Performance on a cognitive test battery at baseline will be compared to performance at week 6
- Secondary Outcome Measures
Name Time Method Salivary cortisol change from baseline Week 1 (baseline) and week 6 Salivettes will be used to collect salivary cortisol response across exposure to a laboratory stress protocol on two occasions separated by 6 weeks
Blood pressure (systolic/diastolic) change from baseline Week 1 (baseline) and week 6 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
Heart rate change from baseline Week 1 (baseline) and 6 weeks 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
Subjective stress change from baseline Week 1 (baseline) and 6 weeks 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
Subjective mood change from baseline Week 1 (baseline) and 6 weeks 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
Trial Locations
- Locations (1)
Human Appetite Research Unit, University of Leeds
🇬🇧Leeds, West Yorkshire, United Kingdom
Human Appetite Research Unit, University of Leeds🇬🇧Leeds, West Yorkshire, United Kingdom