The Effect of a Phospholipid Drink on Cognitive Performance Under Acute Stress

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomised, Double-blind, Parallel Groups, Placebo-controlled 6 Weeks Human Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance

Conditions
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Cognitive Performance (Focus)

Intervention / Treatment
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* Dietary Supplement: Phospholipid drink
* Dietary Supplement: Placebo milk drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phospholipid drink<br>Participants will consume a phospholipid drink daily for 6 weeks | Dietary Supplement: Phospholipid drink<br>* Participant in an intervention parallel group will consume a drink with added phospholipids<br>|
| Placebo Comparator: Placebo milk drink<br>Participants will consume a placebo drink (no added phospholipids) daily for 6 weeks | Dietary Supplement: Placebo milk drink<br>* Participant in an intervention parallel group will consume a drink without added phospholipids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory, Attention