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Nutrients to Enhance Sleep Quality and Quantity

Primary Purpose

Sleepiness in Athletes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tryptophan
Sponsored by
PepsiCo Global R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleepiness in Athletes

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-40 year old males

Exclusion Criteria:

  • Exclusion: Exclusion criteria will include any observed or disclosed injury, illness, sleep or health issue which may disrupt the subject's performance or endanger their health. Participants will need to complete an adult screening tool, as recommended by Exercise and Sports Science Australia (ESSA), to assess this.
  • Blood samples will also be collected to screen for magnesium, zinc and B12 which may influence nutritional impact on sleep. If subjects score above the reference ranges for these measures, they will be excluded.
  • The Pittsburg Sleep Quality Index (PSQI) and Stanford Sleepiness Scale (SSS) will be used to screen for sleep disturbances. If subjects score outside the reference ranges for these questionnaires, they will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Triptophan beverage

    Arm Description

    Proprietary blend of nutritional interventions aimed at increasing sleepiness

    Outcomes

    Primary Outcome Measures

    polysomnography
    The effect of the drinks will be determined primarily by polysomnography

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2017
    Last Updated
    September 13, 2018
    Sponsor
    PepsiCo Global R&D
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03288077
    Brief Title
    Nutrients to Enhance Sleep Quality and Quantity
    Official Title
    Nutrients to Enhance Sleep Quality and Quantity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (Actual)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    August 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    PepsiCo Global R&D

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Identifying non-pharmacological means of enhancing sleep is an important area of research for elite athletes. Research completed at the AIS has identified that some athletes have difficulties falling and staying asleep during both training and competition. There are a number of dietary components such as nutrients and certain dietary supplements that are purported to decrease sleep latency and increase quality of sleep. While many of these interventions have been investigated in isolation, no research has examined different combinations and/or amounts of these substances to determine the resultant effects on sleep. The results of such a systematic investigation could produce an effective diet based sleep product ("Sleep Drink'). The optimal components, amounts, and timing of intake of such a Sleep Drink will be explored. Additionally, the effects on sleep will be evaluated using the gold standard of sleep measurement: polysomnography.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleepiness in Athletes

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Triptophan beverage
    Arm Type
    Experimental
    Arm Description
    Proprietary blend of nutritional interventions aimed at increasing sleepiness
    Intervention Type
    Other
    Intervention Name(s)
    Tryptophan
    Intervention Description
    Beverage including tryptophan
    Primary Outcome Measure Information:
    Title
    polysomnography
    Description
    The effect of the drinks will be determined primarily by polysomnography
    Time Frame
    0-3 hours

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-40 year old males Exclusion Criteria: Exclusion: Exclusion criteria will include any observed or disclosed injury, illness, sleep or health issue which may disrupt the subject's performance or endanger their health. Participants will need to complete an adult screening tool, as recommended by Exercise and Sports Science Australia (ESSA), to assess this. Blood samples will also be collected to screen for magnesium, zinc and B12 which may influence nutritional impact on sleep. If subjects score above the reference ranges for these measures, they will be excluded. The Pittsburg Sleep Quality Index (PSQI) and Stanford Sleepiness Scale (SSS) will be used to screen for sleep disturbances. If subjects score outside the reference ranges for these questionnaires, they will be excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shona Halson, PhD
    Organizational Affiliation
    AIS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Nutrients to Enhance Sleep Quality and Quantity

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