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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Timepoint [1] 0 0
Time from sleep onset to 8:00 a.m.
Primary outcome [2] 0 0
Wake After Sleep Onset (WASO)
Timepoint [2] 0 0
From sleep onset till 8:00 a.m.
Primary outcome [3] 0 0
Sleep Efficiency (SE)
Timepoint [3] 0 0
From sleep onset to 8:00 a.m.
Primary outcome [4] 0 0
Sleep Onset Latency (SOL)
Timepoint [4] 0 0
Transition from wakefulness to sleep
Primary outcome [5] 0 0
Rapid Eye Movement (REM) Latency
Timepoint [5] 0 0
From sleep onset to REM sleep
Primary outcome [6] 0 0
Sleep stage 3 Latency
Timepoint [6] 0 0
From sleep onset to deep sleep
Primary outcome [7] 0 0
Sleep stage 1, 2, 3 AND REM
Timepoint [7] 0 0
Measured continuously throughout the night from sleep onset to 8 a.m.
Primary outcome [8] 0 0
Arousals
Timepoint [8] 0 0
From sleep onset to 8 a.m.
Primary outcome [9] 0 0
Awakenings
Timepoint [9] 0 0
From sleep onset to 8 a.m.
Primary outcome [10] 0 0
Stage shifts
Timepoint [10] 0 0
From sleep onset to 8 a.m.
Primary outcome [11] 0 0
Subjective Karolinska Sleepiness Scale (KSS)
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
Timepoint [12] 0 0
08:30 a.m. following polysomnography
Primary outcome [13] 0 0
(Subjective) Sleep Quantity
Timepoint [13] 0 0
08:30 a.m. following polysomnography
Primary outcome [14] 0 0
(Subjective) Sleep Onset Latency
Timepoint [14] 0 0
08:30 a.m. following polysomnography
Secondary outcome [1] 0 0
Exercise performance: power output
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
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
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
Timepoint [4] 0 0
10 minute testing period at 9 a.m. Higher performance is better.
Secondary outcome [5] 0 0
Subjective alertness
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
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
Timepoint [7] 0 0
9 a.m. before cognitive performance attention testing
Secondary outcome [8] 0 0
Balance
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
Sex
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
Other
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2022
Sample size
Target
Accrual to date
Final
19
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/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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