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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01879813
Enrollment
54
Registered
2013-06-18
Start date
2012-10-31
Completion date
2013-08-31
Last updated
2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Performance (Focus)

Keywords

Memory, Attention

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

Interventions

DIETARY_SUPPLEMENTPhospholipid drink

Participant in an intervention parallel group will consume a drink with added phospholipids

DIETARY_SUPPLEMENTPlacebo milk drink

Participant in an intervention parallel group will consume a drink without added phospholipids

Sponsors

Arla Foods
CollaboratorINDUSTRY
University of Leeds
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive performance change from baselineWeek 1 (baseline) and week 6Performance on a cognitive test battery at baseline will be compared to performance at week 6

Secondary

MeasureTime frameDescription
Salivary cortisol change from baselineWeek 1 (baseline) and week 6Salivettes 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 6An 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 weeksAn 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 weeksThe 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 weeksThe 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026