CClinicalTrials.gg
CompletedNCT03288077Updated Sep 14, 2018

Nutrients to Enhance Sleep Quality and Quantity

An interventional study of Tryptophan in Sleepiness in Athletes, sponsored by PepsiCo Global R&D. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-14.

Sponsored by PepsiCo Global R&D · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Male
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Study 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.

02

Conditions studied

  • Sleepiness in Athletes

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03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18-40 year old males

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Triptophan beverage

    Proprietary blend of nutritional interventions aimed at increasing sleepiness

    Other: Tryptophan

Interventions

  • OtherTryptophan

    Beverage including tryptophan

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What researchers measure

Primary outcomes

  1. polysomnography

    The effect of the drinks will be determined primarily by polysomnography

    Time frame: 0-3 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03288077
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Jun 2015
Primary completion
Jun 2018
Completion
Aug 2018
Last update
Sep 14, 2018

Study contacts

Shona Halson, PhD
principal investigator · AIS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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