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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leeds

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arla Foods

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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