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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05032729




Registration number
NCT05032729
Ethics application status
Date submitted
13/08/2021
Date registered
2/09/2021
Date last updated
2/09/2021

Titles & IDs
Public title
Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
Scientific title
Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
Secondary ID [1] 0 0
PEP-1911
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 0 0
Physical Performance 0 0
Cognitive Performance 0 0
Balance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Trypophan, Theanine and 5'AMP
Other interventions - Placebo

Placebo Comparator: Placebo beverage - Flavor
Non-nutritive sweetener
Color added to match whey appearance

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

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 interventions: Trypophan, Theanine and 5'AMP
250 ml beverage consumed at 21:00 hours

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total Sleep Time (TST) - Measured in minutes during polysomnography. Longer is better.
Timepoint [1] 0 0
Time from sleep onset to 8:00 a.m.
Primary outcome [2] 0 0
Wake After Sleep Onset (WASO) - Occurrences measured in minutes during polysomnography. None or less are better.
Timepoint [2] 0 0
From sleep onset till 8:00 a.m.
Primary outcome [3] 0 0
Sleep Efficiency (SE) - Measured as a % of time asleep over time in bed during polysomnography. Higher efficiency is better
Timepoint [3] 0 0
From sleep onset to 8:00 a.m.
Primary outcome [4] 0 0
Sleep Onset Latency (SOL) - Measured in minutes during polysomnography. Shorter time to onset is better.
Timepoint [4] 0 0
Transition from wakefulness to sleep
Primary outcome [5] 0 0
Rapid Eye Movement (REM) Latency - Measured in minutes during polysomnography. Shorter time to REM is better.
Timepoint [5] 0 0
From sleep onset to REM sleep
Primary outcome [6] 0 0
Sleep stage 3 Latency - Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.
Timepoint [6] 0 0
From sleep onset to deep sleep
Primary outcome [7] 0 0
Sleep stage 1, 2, 3 AND REM - Measured in minutes during polysomnography. Normal stage pattern is better.
Timepoint [7] 0 0
Measured continuously throughout the night from sleep onset to 8 a.m.
Primary outcome [8] 0 0
Arousals - Measured as a count during polysomnography. Less arousals are better.
Timepoint [8] 0 0
From sleep onset to 8 a.m.
Primary outcome [9] 0 0
Awakenings - Measured as a count during polysomnography. Less awakenings are better.
Timepoint [9] 0 0
From sleep onset to 8 a.m.
Primary outcome [10] 0 0
Stage shifts - Measured as a count during polysomnography. Normal amount of stage shifts are better.
Timepoint [10] 0 0
From sleep onset to 8 a.m.
Primary outcome [11] 0 0
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.
Timepoint [11] 0 0
Every thirty minutes from 20:00 p.m. until 22:30 p.m.
Primary outcome [12] 0 0
(Subjective) Perceived Sleep Quality - Rated from 1 (very good) to 5 (poor). Lower number is better.
Timepoint [12] 0 0
08:30 a.m. following polysomnography
Primary outcome [13] 0 0
(Subjective) Sleep Quantity - Measured in hours and minutes. Higher number is better.
Timepoint [13] 0 0
08:30 a.m. following polysomnography
Primary outcome [14] 0 0
(Subjective) Sleep Onset Latency - Measured in hours and minutes. Lower number is better.
Timepoint [14] 0 0
08:30 a.m. following polysomnography
Secondary outcome [1] 0 0
Exercise performance: power output - Cycle ergometer to measure power output in watts, with instructions to give maximal effort. Higher watts are better.
Timepoint [1] 0 0
During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Secondary outcome [2] 0 0
Exercise performance: perceived exertion - Rating of perceived exertion (RPE) on a scale of 6 (lower) to 20 (higher) intensity levels.
Timepoint [2] 0 0
During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Secondary outcome [3] 0 0
Exercise performance: heart rate - Measured in beats per minute (bpm) by heart rate monitor
Timepoint [3] 0 0
During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Secondary outcome [4] 0 0
Cognitive performance: sustained attention - Psychomotor vigilance reaction time task (PVT-192) handheld ambulatory monitoring
Timepoint [4] 0 0
10 minute testing period at 9 a.m. Higher performance is better.
Secondary outcome [5] 0 0
Subjective alertness - Rated on visual analog scale from 0 (feeling not at all alert) to 100 (feeling completely alert). Feeling more alert is better.
Timepoint [5] 0 0
9 a.m. before cognitive performance attention testing.
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
9 a.m. before cognitive performance attention testing
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
9 a.m. before cognitive performance attention testing
Secondary outcome [8] 0 0
Balance - Postural sway area 95cm/2 measured by computerized force platform. Less sway is better.
Timepoint [8] 0 0
9 a.m. before cognitive performance attention testing.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus - Wayville
Recruitment postcode(s) [1] 0 0
5034 - Wayville

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PepsiCo Global R&D
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT05032729
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shona Halson, PhD
Address 0 0
Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shona Halson, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 422224491
Fax 0 0
Email 0 0
shona.halson@acu.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05032729