Clinical trial NCT01879813: The Effect of a Phospholipid Drink on Cognitive Performance Under Acute Stress
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance (Focus)
Keywords: Memory
Attention
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Arla Foods
First posted: 2013-06-18
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive performance change from baseline
timeFrame: Week 1 (baseline) and week 6
Secondary outcomes:
measure: Salivary cortisol change from baseline
timeFrame: Week 1 (baseline) and week 6
measure: Blood pressure (systolic/diastolic) change from baseline
timeFrame: Week 1 (baseline) and week 6
measure: Heart rate change from baseline
timeFrame: Week 1 (baseline) and 6 weeks
measure: Subjective stress change from baseline
timeFrame: Week 1 (baseline) and 6 weeks
measure: Subjective mood change from baseline
timeFrame: Week 1 (baseline) and 6 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Human Appetite Research Unit, University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Louise Dye, PhD
role: PRINCIPAL_INVESTIGATOR
References: