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

Not Applicable
Completed
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
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
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

Human Appetite Research Unit, University of Leeds
🇬🇧Leeds, West Yorkshire, United Kingdom

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