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

May 19, 2014 updated by: Prof Louise Dye, University of Leeds

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS29JT
        • Human Appetite Research Unit, University of Leeds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive performance change from baseline
Time Frame: Week 1 (baseline) and week 6
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
Time Frame: Week 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
Week 1 (baseline) and week 6
Blood pressure (systolic/diastolic) change from baseline
Time Frame: Week 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
Week 1 (baseline) and week 6
Heart rate change from baseline
Time Frame: Week 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
Week 1 (baseline) and 6 weeks
Subjective stress change from baseline
Time Frame: Week 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
Week 1 (baseline) and 6 weeks
Subjective mood change from baseline
Time Frame: Week 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
Week 1 (baseline) and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

Arla Foods

Investigators

  • Principal Investigator: Louise Dye, PhD, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Stress and cognition study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Performance (Focus)

Clinical Trials on Phospholipid drink

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe