Nutrients to Enhance Sleep Quality and Quantity

NCT03288077 | Completed

• 1 other identifier: PEP-1420
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleepiness in Athletes

Outcome Measures

Primary Outcomes (1)

• polysomnography

  The effect of the drinks will be determined primarily by polysomnography

  0-3 hours

Study Arms (1)

Triptophan beverage

EXPERIMENTAL

Proprietary blend of nutritional interventions aimed at increasing sleepiness

Other: Tryptophan

Interventions

Tryptophan OTHER

Beverage including tryptophan

Triptophan beverage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• year old males

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

MeSH Terms

Interventions

Tryptophan

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Shona Halson, PhD

  AIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 19, 2017
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share