Nutrients to Enhance Sleep Quality and Quantity

Not Applicable

Completed

• Conditions: Sleepiness in Athletes
• Interventions: Other: Tryptophan

• Registration Number: NCT03288077
• Lead Sponsor: PepsiCo Global R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-19
• Primary Completion: 2018-06
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triptophan beverage	Tryptophan	Proprietary blend of nutritional interventions aimed at increasing sleepiness

Primary Outcome Measures

Name	Time	Method
polysomnography	0-3 hours	The effect of the drinks will be determined primarily by polysomnography