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

NCT ID: NCT01879813

Last Updated: 2014-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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

Conditions

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Cognitive Performance (Focus)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phospholipid drink

Participants will consume a phospholipid drink daily for 6 weeks

Group Type ACTIVE_COMPARATOR

Phospholipid drink

Intervention Type DIETARY_SUPPLEMENT

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

Placebo milk drink

Participants will consume a placebo drink (no added phospholipids) daily for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo milk drink

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Phospholipid drink

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

Intervention Type DIETARY_SUPPLEMENT

Placebo milk drink

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arla Foods

INDUSTRY

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Prof Louise Dye

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise Dye, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Stress and cognition study

Identifier Type: -

Identifier Source: org_study_id

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