Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

Not Applicable

Completed

• Conditions: Cognitive Performance; Sleep; Physical Performance; Balance
• Interventions: Other: Placebo; Other: Trypophan, Theanine and 5'AMP

• Registration Number: NCT05032729
• Lead Sponsor: PepsiCo Global R&D

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-02
• Study Start: 2022-03-14
• Primary Completion: 2022-08-09
• Study Completion: 2022-08-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo beverage	Placebo	* Flavor * Non-nutritive sweetener * Color added to match whey appearance
Higher tryptophan beverage	Trypophan, Theanine and 5'AMP	* 2.7g high Glycemic Index Carbohydrate * 40g whey * 0.855g tryptophan * 660mg theanine * 53mcg 5'AMP * Non-nutritive sweetener * Flavor
Lower tryptophan beverage	Trypophan, Theanine and 5'AMP	* 2.7g high Glycemic Index Carbohydrate * 30g whey * 0.641g tryptophan * 660mg theanine * 53mcg 5'AMP * Non-nutritive sweetener * Flavor

Primary Outcome Measures

Name	Time	Method
Total Sleep Time (TST)	Time from sleep onset to 8:00 a.m.	Measured in minutes during polysomnography. Longer is better.
Arousals	From sleep onset to 8 a.m.	Measured as a count during polysomnography. Less arousals are better.
Rapid Eye Movement (REM) Latency	From sleep onset to REM sleep	Measured in minutes during polysomnography. Shorter time to REM is better.
Wake After Sleep Onset (WASO)	From sleep onset till 8:00 a.m.	Occurrences measured in minutes during polysomnography. None or less are better.
Sleep Efficiency (SE)	From sleep onset to 8:00 a.m.	Measured as a % of time asleep over time in bed during polysomnography. Higher efficiency is better
Sleep stage 1, 2, 3 AND REM	Measured continuously throughout the night from sleep onset to 8 a.m.	Measured in minutes during polysomnography. Normal stage pattern is better.
Stage shifts	From sleep onset to 8 a.m.	Measured as a count during polysomnography. Normal amount of stage shifts are better.
Sleep Onset Latency (SOL)	Transition from wakefulness to sleep	Measured in minutes during polysomnography. Shorter time to onset is better.
Sleep stage 3 Latency	From sleep onset to deep sleep	Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.
Awakenings	From sleep onset to 8 a.m.	Measured as a count during polysomnography. Less awakenings are better.
Subjective Karolinska Sleepiness Scale (KSS)	Every thirty minutes from 20:00 p.m. until 22:30 p.m.	Subjective arousal level at present state rated 1 (extremely alert) to 9 (Very sleepy, great effort to keep awake). Sleepiness before bed is better.
(Subjective) Perceived Sleep Quality	08:30 a.m. following polysomnography	Rated from 1 (very good) to 5 (poor). Lower number is better.
(Subjective) Sleep Quantity	08:30 a.m. following polysomnography	Measured in hours and minutes. Higher number is better.
(Subjective) Sleep Onset Latency	08:30 a.m. following polysomnography	Measured in hours and minutes. Lower number is better.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus; 🇦🇺 Wayville, South Australia, Australia