Nutrients to Enhance Sleep Quality and Quantity

NCT ID: NCT03288077

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Sleepiness in Athletes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Triptophan beverage

Proprietary blend of nutritional interventions aimed at increasing sleepiness

Group Type EXPERIMENTAL

Tryptophan

Intervention Type OTHER

Beverage including tryptophan

Interventions

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Tryptophan

Beverage including tryptophan

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-40 year old males

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shona Halson, PhD

Role: PRINCIPAL_INVESTIGATOR

AIS

Other Identifiers

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PEP-1420

Identifier Type: -

Identifier Source: org_study_id

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