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
About this trial
This is an interventional basic science trial for Sleepiness in Athletes
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.
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
NCT ID
NCT03288077
First Posted
September 18, 2017
Last Updated
September 13, 2018
Sponsor
PepsiCo Global R&D
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
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Nutrients to Enhance Sleep Quality and Quantity
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