Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

NCT05032729 | Completed

• 1 other identifier: PEP-1911
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the impact of two nutritional interventions vs. placebo on objective and subjective sleep measures in athletes. Participants receive one beverage on each of three consecutive nights in a randomized manner. It is hypothesized the two nutritional interventions will result in significant improvements in sleep onset latency, and will not result in a negative impact on next-day cycling performance. The secondary objective is to assess the impact of the nutritional interventions vs. placebo on next-morning performance (physical, cognitive function, and balance).

Conditions

Sleep; Physical Performance; Cognitive Performance; Balance

Keywords

nutrition; sleep; polysomnography; performance; exercise

Outcome Measures

Primary Outcomes (14)

• Total Sleep Time (TST)

  Measured in minutes during polysomnography. Longer is better.

  Time from sleep onset to 8:00 a.m.

• Wake After Sleep Onset (WASO)

  Occurrences measured in minutes during polysomnography. None or less are better.

  From sleep onset till 8:00 a.m.

• Sleep Efficiency (SE)

  Measured as a % of time asleep over time in bed during polysomnography. Higher efficiency is better

  From sleep onset to 8:00 a.m.

• Sleep Onset Latency (SOL)

  Measured in minutes during polysomnography. Shorter time to onset is better.

  Transition from wakefulness to sleep

• Rapid Eye Movement (REM) Latency

  Measured in minutes during polysomnography. Shorter time to REM is better.

  From sleep onset to REM sleep

• Sleep stage 3 Latency

  Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.

  From sleep onset to deep sleep

• Sleep stage 1, 2, 3 AND REM

  Measured in minutes during polysomnography. Normal stage pattern is better.

  Measured continuously throughout the night from sleep onset to 8 a.m.

• Arousals

  Measured as a count during polysomnography. Less arousals are better.

  From sleep onset to 8 a.m.

• Awakenings

  Measured as a count during polysomnography. Less awakenings are better.

  From sleep onset to 8 a.m.

• Stage shifts

  Measured as a count during polysomnography. Normal amount of stage shifts are better.

  From sleep onset to 8 a.m.

• Subjective Karolinska Sleepiness Scale (KSS)

  Subjective arousal level at present state rated 1 (extremely alert) to 9 (Very sleepy, great effort to keep awake). Sleepiness before bed is better.

  Every thirty minutes from 20:00 p.m. until 22:30 p.m.

• (Subjective) Perceived Sleep Quality

  Rated from 1 (very good) to 5 (poor). Lower number is better.

  08:30 a.m. following polysomnography

• (Subjective) Sleep Quantity

  Measured in hours and minutes. Higher number is better.

  08:30 a.m. following polysomnography

• (Subjective) Sleep Onset Latency

  Measured in hours and minutes. Lower number is better.

  08:30 a.m. following polysomnography

Secondary Outcomes (8)

• Exercise performance: power output

  During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.

• Exercise performance: perceived exertion

  During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.

• Exercise performance: heart rate

  During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.

• Cognitive performance: sustained attention

  10 minute testing period at 9 a.m. Higher performance is better.

• Subjective alertness

  9 a.m. before cognitive performance attention testing.

Study Arms (3)

Placebo beverage

PLACEBO COMPARATOR

* Flavor * Non-nutritive sweetener * Color added to match whey appearance

Other: Placebo

Higher tryptophan beverage

EXPERIMENTAL

* 2.7g high Glycemic Index Carbohydrate * 40g whey * 0.855g tryptophan * 660mg theanine * 53mcg 5'AMP * Non-nutritive sweetener * Flavor

Other: Trypophan, Theanine and 5'AMP

Lower tryptophan beverage

EXPERIMENTAL

* 2.7g high Glycemic Index Carbohydrate * 30g whey * 0.641g tryptophan * 660mg theanine * 53mcg 5'AMP * Non-nutritive sweetener * Flavor

Other: Trypophan, Theanine and 5'AMP

Interventions

Trypophan, Theanine and 5'AMP OTHER

250 ml beverage consumed at 21:00 hours

Higher tryptophan beverage; Lower tryptophan beverage

Placebo OTHER

250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages

Placebo beverage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Biological males due to the influence that menstrual cycle may have on sleep and the study aims to investigate previous findings involving male only participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• years old
• Healthy (assessed via the Exercise and Sports Science Australia (ESSA) survey
• Endurance trained (2 hours of training at least 3 days per week for a minimum of 3 years)
• Free from any known sleep disorders or disturbances as assessed by a Pittsburg Sleep Quality Index (PSQI score under 5)
• Must be willing to live/sleep at the Appleton Institute Sleep Laboratory for 4 (consecutive) nights/5 days (total 96 hours)
• Must be able to provide written informed consent upon having the study procedure explained to them verbally and in writing.
• Willing to be prohibited from consuming caffeine and alcohol during the entire stay at the sleep clinic and agree to eat only the standardized meals and snacks and drinks provided.

You may not qualify if:

• Subject has a clinically diagnosed sleeping disorder
• Subject has a change in medication over the duration of the study that is known to affect sleep
• Subject has a current illness that would affect sleep
• Subject has a current injury that would prevent him from giving maximal effort during the next-morning performance task
• Participation in another clinical trial within the past 30 days or another PepsiCo/GSSI study within the past 6 months

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus

Wayville, South Australia, 5034, Australia

Location

MeSH Terms

Conditions

Motor Activity

Interventions

theanine

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Shona Halson, PhD

  Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 2, 2021
• Study Start: March 14, 2022
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)