Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

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).

Study Overview

• Status: Completed
• Conditions: Sleep; Cognitive Performance; Balance; Physical Performance
• Intervention / Treatment: Other: Placebo; Other: Trypophan, Theanine and 5'AMP

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Wayville, South Australia, Australia, 5034
      • Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male
• 18-40 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo beverage; Flavor; Non-nutritive sweetener; Color added to match whey appearance	Other: Placebo; 250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages
EXPERIMENTAL: Higher tryptophan beverage; 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; 250 ml beverage consumed at 21:00 hours
EXPERIMENTAL: Lower tryptophan beverage; 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; 250 ml beverage consumed at 21:00 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise performance: power output	Cycle ergometer to measure power output in watts, with instructions to give maximal effort. Higher watts are better.	During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Exercise performance: perceived exertion	Rating of perceived exertion (RPE) on a scale of 6 (lower) to 20 (higher) intensity levels.	During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Exercise performance: heart rate	Measured in beats per minute (bpm) by heart rate monitor	During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Cognitive performance: sustained attention	Psychomotor vigilance reaction time task (PVT-192) handheld ambulatory monitoring	10 minute testing period at 9 a.m. Higher performance is better.
Subjective alertness	Rated on visual analog scale from 0 (feeling not at all alert) to 100 (feeling completely alert). Feeling more alert is better.	9 a.m. before cognitive performance attention testing.
Subjective self-perceived capacity to be fast on cognitive test	Rated on visual analog scale from 0 (expecting to not respond fast at all) to 100 (expecting to respond very fast). Better or worse not applicable.	9 a.m. before cognitive performance attention testing
Subjective self-perceived capacity to be accurate on cognitive test	Rated on visual analog scale from 0 (expecting to not respond accurately at all) to 100 (expecting to respond very accurately). Better or worse not applicable.	9 a.m. before cognitive performance attention testing
Balance	Postural sway area 95cm/2 measured by computerized force platform. Less sway is better.	9 a.m. before cognitive performance attention testing.

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Shona Halson, PhD, Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2022
• Primary Completion (ACTUAL): August 9, 2022
• Study Completion (ACTUAL): August 9, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (ACTUAL): September 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: polysomnography; exercise; sleep; nutrition; performance
• Other Study ID Numbers: PEP-1911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No