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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05032729
Registration number
NCT05032729
Ethics application status
Date submitted
13/08/2021
Date registered
2/09/2021
Date last updated
15/11/2022
Titles & IDs
Public title
Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
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Scientific title
Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
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Secondary ID [1]
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PEP-1911
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep
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Physical Performance
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Cognitive Performance
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Balance
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total Sleep Time (TST)
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Assessment method [1]
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Measured in minutes during polysomnography. Longer is better.
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Timepoint [1]
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Time from sleep onset to 8:00 a.m.
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Primary outcome [2]
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Wake After Sleep Onset (WASO)
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Assessment method [2]
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Occurrences measured in minutes during polysomnography. None or less are better.
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Timepoint [2]
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From sleep onset till 8:00 a.m.
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Primary outcome [3]
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Sleep Efficiency (SE)
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Assessment method [3]
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Measured as a % of time asleep over time in bed during polysomnography. Higher efficiency is better
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Timepoint [3]
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From sleep onset to 8:00 a.m.
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Primary outcome [4]
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Sleep Onset Latency (SOL)
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Assessment method [4]
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Measured in minutes during polysomnography. Shorter time to onset is better.
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Timepoint [4]
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Transition from wakefulness to sleep
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Primary outcome [5]
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Rapid Eye Movement (REM) Latency
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Assessment method [5]
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Measured in minutes during polysomnography. Shorter time to REM is better.
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Timepoint [5]
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From sleep onset to REM sleep
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Primary outcome [6]
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Sleep stage 3 Latency
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Assessment method [6]
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Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.
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Timepoint [6]
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From sleep onset to deep sleep
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Primary outcome [7]
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Sleep stage 1, 2, 3 AND REM
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Assessment method [7]
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Measured in minutes during polysomnography. Normal stage pattern is better.
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Timepoint [7]
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Measured continuously throughout the night from sleep onset to 8 a.m.
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Primary outcome [8]
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Arousals
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Assessment method [8]
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Measured as a count during polysomnography. Less arousals are better.
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Timepoint [8]
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From sleep onset to 8 a.m.
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Primary outcome [9]
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Awakenings
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Assessment method [9]
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Measured as a count during polysomnography. Less awakenings are better.
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Timepoint [9]
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From sleep onset to 8 a.m.
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Primary outcome [10]
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Stage shifts
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Assessment method [10]
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Measured as a count during polysomnography. Normal amount of stage shifts are better.
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Timepoint [10]
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From sleep onset to 8 a.m.
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Primary outcome [11]
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Subjective Karolinska Sleepiness Scale (KSS)
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Assessment method [11]
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Subjective arousal level at present state rated 1 (extremely alert) to 9 (Very sleepy, great effort to keep awake). Sleepiness before bed is better.
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Timepoint [11]
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Every thirty minutes from 20:00 p.m. until 22:30 p.m.
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Primary outcome [12]
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(Subjective) Perceived Sleep Quality
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Assessment method [12]
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Rated from 1 (very good) to 5 (poor). Lower number is better.
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Timepoint [12]
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08:30 a.m. following polysomnography
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Primary outcome [13]
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(Subjective) Sleep Quantity
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Assessment method [13]
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Measured in hours and minutes. Higher number is better.
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Timepoint [13]
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08:30 a.m. following polysomnography
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Primary outcome [14]
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(Subjective) Sleep Onset Latency
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Assessment method [14]
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Measured in hours and minutes. Lower number is better.
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Timepoint [14]
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08:30 a.m. following polysomnography
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Secondary outcome [1]
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Exercise performance: power output
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Assessment method [1]
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Cycle ergometer to measure power output in watts, with instructions to give maximal effort. Higher watts are better.
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Timepoint [1]
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During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
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Secondary outcome [2]
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Exercise performance: perceived exertion
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Assessment method [2]
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Rating of perceived exertion (RPE) on a scale of 6 (lower) to 20 (higher) intensity levels.
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Timepoint [2]
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During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
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Secondary outcome [3]
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Exercise performance: heart rate
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Assessment method [3]
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Measured in beats per minute (bpm) by heart rate monitor
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Timepoint [3]
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During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
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Secondary outcome [4]
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Cognitive performance: sustained attention
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Assessment method [4]
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Psychomotor vigilance reaction time task (PVT-192) handheld ambulatory monitoring
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Timepoint [4]
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10 minute testing period at 9 a.m. Higher performance is better.
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Secondary outcome [5]
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Subjective alertness
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Assessment method [5]
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Rated on visual analog scale from 0 (feeling not at all alert) to 100 (feeling completely alert). Feeling more alert is better.
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Timepoint [5]
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9 a.m. before cognitive performance attention testing.
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Secondary outcome [6]
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Subjective self-perceived capacity to be fast on cognitive test
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Assessment method [6]
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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.
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Timepoint [6]
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9 a.m. before cognitive performance attention testing
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Secondary outcome [7]
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Subjective self-perceived capacity to be accurate on cognitive test
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Assessment method [7]
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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.
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Timepoint [7]
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9 a.m. before cognitive performance attention testing
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Secondary outcome [8]
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Balance
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Assessment method [8]
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Postural sway area 95cm/2 measured by computerized force platform. Less sway is better.
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Timepoint [8]
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9 a.m. before cognitive performance attention testing.
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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.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2022
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Sample size
Target
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Accrual to date
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Final
19
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus - Wayville
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Recruitment postcode(s) [1]
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5034 - Wayville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
PepsiCo Global R&D
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05032729
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Shona Halson, PhD
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Address
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Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05032729
Download to PDF