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OpenTrials
Completed

NCT Number: NCT03288077

Nutrients to Enhance Sleep Quality and Quantity

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.

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Key information

Conditions

Sleepiness in Athletes

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tryptophan

Other

Beverage including tryptophan

Primary outcomes

  1. polysomnography

    Time frame: 0-3 hours

    The effect of the drinks will be determined primarily by polysomnography

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2017
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.