Status:
COMPLETED
Nutrients to Enhance Sleep Quality and Quantity
Lead Sponsor:
PepsiCo Global R&D
Conditions:
Sleepiness in Athletes
Eligibility:
MALE
18-40 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 18-40 year old males
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03288077
Start Date
June 1 2015
End Date
August 1 2018
Last Update
September 14 2018
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