Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

Sleep Clinical Trial

Official title:

Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032729
• Other study ID #: PEP-1911
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: August 9, 2022

Study information

• Verified date: November 2022
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Balance
• Cognitive Performance
• Physical Performance
• Sleep

Intervention

Other:
• Trypophan, Theanine and 5'AMP
250 ml beverage consumed at 21:00 hours
• Placebo
250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages

Locations

Country	Name	City	State
Australia	Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus	Wayville	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time (TST)	Measured in minutes during polysomnography. Longer is better.	Time from sleep onset to 8:00 a.m.
Primary	Wake After Sleep Onset (WASO)	Occurrences measured in minutes during polysomnography. None or less are better.	From sleep onset till 8:00 a.m.
Primary	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.
Primary	Sleep Onset Latency (SOL)	Measured in minutes during polysomnography. Shorter time to onset is better.	Transition from wakefulness to sleep
Primary	Rapid Eye Movement (REM) Latency	Measured in minutes during polysomnography. Shorter time to REM is better.	From sleep onset to REM sleep
Primary	Sleep stage 3 Latency	Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.	From sleep onset to deep sleep
Primary	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.
Primary	Arousals	Measured as a count during polysomnography. Less arousals are better.	From sleep onset to 8 a.m.
Primary	Awakenings	Measured as a count during polysomnography. Less awakenings are better.	From sleep onset to 8 a.m.
Primary	Stage shifts	Measured as a count during polysomnography. Normal amount of stage shifts are better.	From sleep onset to 8 a.m.
Primary	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.
Primary	(Subjective) Perceived Sleep Quality	Rated from 1 (very good) to 5 (poor). Lower number is better.	08:30 a.m. following polysomnography
Primary	(Subjective) Sleep Quantity	Measured in hours and minutes. Higher number is better.	08:30 a.m. following polysomnography
Primary	(Subjective) Sleep Onset Latency	Measured in hours and minutes. Lower number is better.	08:30 a.m. following polysomnography
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	Balance	Postural sway area 95cm/2 measured by computerized force platform. Less sway is better.	9 a.m. before cognitive performance attention testing.