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

Not Applicable
Completed
Conditions
Cognitive Performance (Focus)
Interventions
Dietary Supplement: Phospholipid drink
Dietary Supplement: Placebo milk drink
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Phospholipid drinkPhospholipid drinkParticipants will consume a phospholipid drink daily for 6 weeks
Placebo milk drinkPlacebo milk drinkParticipants will consume a placebo drink (no added phospholipids) daily for 6 weeks
Primary Outcome Measures
NameTimeMethod
Cognitive performance change from baselineWeek 1 (baseline) and week 6

Performance on a cognitive test battery at baseline will be compared to performance at week 6

Secondary Outcome Measures
NameTimeMethod
Salivary cortisol change from baselineWeek 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 baselineWeek 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 baselineWeek 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 baselineWeek 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 baselineWeek 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

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