SleepNCT05032729
Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
A study testing Trypophan, Theanine and 5'AMP in people with Sleep and Physical Performance, run by PepsiCo Global R&D at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Physical Performance, Cognitive Performance
- What is being tested?
- Trypophan, Theanine and 5'AMP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Mar 2022to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus
Wayville, South Australia, 5034
About this study
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).
- Conditions
- Sleep, Physical Performance, Cognitive Performance, Balance
- Being tested
- Trypophan, Theanine and 5'AMP, Placebo
- Keywords
- nutrition, sleep, polysomnography, performance, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trypophan, Theanine and 5'AMPOther
250 ml beverage consumed at 21:00 hours
PlaceboOther
250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages
| Study group | Role | What they receive |
|---|---|---|
| Placebo beverage | Placebo comparator | * Flavor
* Non-nutritive sweetener
* Color added to match whey appearance Receives: Other: Placebo |
| Higher tryptophan beverage | Experimental | * 2.7g high Glycemic Index Carbohydrate
* 40g whey
* 0.855g tryptophan
* 660mg theanine
* 53mcg 5'AMP
* Non-nutritive sweetener
* Flavor Receives: Other: Trypophan, Theanine and 5'AMP |
| Lower tryptophan beverage | Experimental | * 2.7g high Glycemic Index Carbohydrate
* 30g whey
* 0.641g tryptophan
* 660mg theanine
* 53mcg 5'AMP
* Non-nutritive sweetener
* Flavor Receives: Other: Trypophan, Theanine and 5'AMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (TST)
Measured in minutes during polysomnography. Longer is better.
Measured: Time from sleep onset to 8:00 a.m.
Wake After Sleep Onset (WASO)
Occurrences measured in minutes during polysomnography. None or less are better.
Measured: From sleep onset till 8:00 a.m.
Sleep Efficiency (SE)
Measured as a % of time asleep over time in bed during polysomnography. Higher efficiency is better
Measured: From sleep onset to 8:00 a.m.
Sleep Onset Latency (SOL)
Measured in minutes during polysomnography. Shorter time to onset is better.
Measured: Transition from wakefulness to sleep
Rapid Eye Movement (REM) Latency
Measured in minutes during polysomnography. Shorter time to REM is better.
Measured: From sleep onset to REM sleep
Sleep stage 3 Latency
Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.
Measured: From sleep onset to deep sleep
Sleep stage 1, 2, 3 AND REM
Measured in minutes during polysomnography. Normal stage pattern is better.
Measured: Measured continuously throughout the night from sleep onset to 8 a.m.
Arousals
Measured as a count during polysomnography. Less arousals are better.
Measured: From sleep onset to 8 a.m.
Awakenings
Measured as a count during polysomnography. Less awakenings are better.
Measured: From sleep onset to 8 a.m.
Stage shifts
Measured as a count during polysomnography. Normal amount of stage shifts are better.
Measured: From sleep onset to 8 a.m.
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.
Measured: Every thirty minutes from 20:00 p.m. until 22:30 p.m.
(Subjective) Perceived Sleep Quality
Rated from 1 (very good) to 5 (poor). Lower number is better.
Measured: 08:30 a.m. following polysomnography
(Subjective) Sleep Quantity
Measured in hours and minutes. Higher number is better.
Measured: 08:30 a.m. following polysomnography
(Subjective) Sleep Onset Latency
Measured in hours and minutes. Lower number is better.
Measured: 08:30 a.m. following polysomnography
Secondary outcomes (8)
Exercise performance: power output
Cycle ergometer to measure power output in watts, with instructions to give maximal effort. Higher watts are better.
Measured: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Exercise performance: perceived exertion
Rating of perceived exertion (RPE) on a scale of 6 (lower) to 20 (higher) intensity levels.
Measured: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Exercise performance: heart rate
Measured in beats per minute (bpm) by heart rate monitor
Measured: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Cognitive performance: sustained attention
Psychomotor vigilance reaction time task (PVT-192) handheld ambulatory monitoring
Measured: 10 minute testing period at 9 a.m. Higher performance is better.
Subjective alertness
Rated on visual analog scale from 0 (feeling not at all alert) to 100 (feeling completely alert). Feeling more alert is better.
Measured: 9 a.m. before cognitive performance attention testing.
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.
Measured: 9 a.m. before cognitive performance attention testing
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.
Measured: 9 a.m. before cognitive performance attention testing
Balance
Postural sway area 95cm/2 measured by computerized force platform. Less sway is better.
Measured: 9 a.m. before cognitive performance attention testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start14 Mar 2022
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shona Halson, PhD, Principal investigator, Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032729
- Sponsor's protocol ID
- PEP-1911
- Status last verified
- Nov 2022
- First submitted
- 13 Aug 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
- ClinicalTrials.gov ID
- NCT05032729
- Acronym / sponsor ID
- PEP-1911
- Conditions
- Sleep, Physical Performance, Cognitive Performance, Balance
- Keywords
- nutrition, sleep, polysomnography, performance, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo beverage | Placebo comparator | Other: Placebo* Flavor * Non-nutritive sweetener * Color added to match whey appearance |
| Higher tryptophan beverage | Experimental | Other: 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 | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trypophan, Theanine and 5'AMP250 ml beverage consumed at 21:00 hours | Other | Higher tryptophan beverage, Lower tryptophan beverage |
| Placebo250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages | Other | Placebo beverage |
Primary outcome
Total Sleep Time (TST)
Time frame: Time from sleep onset to 8:00 a.m.
Measured in minutes during polysomnography. Longer is better.
Wake After Sleep Onset (WASO)
Time frame: From sleep onset till 8:00 a.m.
Occurrences measured in minutes during polysomnography. None or less are better.
Sleep Efficiency (SE)
Time frame: 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 Onset Latency (SOL)
Time frame: Transition from wakefulness to sleep
Measured in minutes during polysomnography. Shorter time to onset is better.
Rapid Eye Movement (REM) Latency
Time frame: From sleep onset to REM sleep
Measured in minutes during polysomnography. Shorter time to REM is better.
Sleep stage 3 Latency
Time frame: From sleep onset to deep sleep
Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.
Sleep stage 1, 2, 3 AND REM
Time frame: Measured continuously throughout the night from sleep onset to 8 a.m.
Measured in minutes during polysomnography. Normal stage pattern is better.
Arousals
Time frame: From sleep onset to 8 a.m.
Measured as a count during polysomnography. Less arousals are better.
Awakenings
Time frame: From sleep onset to 8 a.m.
Measured as a count during polysomnography. Less awakenings are better.
Stage shifts
Time frame: From sleep onset to 8 a.m.
Measured as a count during polysomnography. Normal amount of stage shifts are better.
Subjective Karolinska Sleepiness Scale (KSS)
Time frame: 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
Time frame: 08:30 a.m. following polysomnography
Rated from 1 (very good) to 5 (poor). Lower number is better.
(Subjective) Sleep Quantity
Time frame: 08:30 a.m. following polysomnography
Measured in hours and minutes. Higher number is better.
(Subjective) Sleep Onset Latency
Time frame: 08:30 a.m. following polysomnography
Measured in hours and minutes. Lower number is better.
8 secondary outcomes
Exercise performance: power output
Time frame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Exercise performance: perceived exertion
Time frame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Exercise performance: heart rate
Time frame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
Cognitive performance: sustained attention
Time frame: 10 minute testing period at 9 a.m. Higher performance is better.
Subjective alertness
Time frame: 9 a.m. before cognitive performance attention testing.
Subjective self-perceived capacity to be fast on cognitive test
Time frame: 9 a.m. before cognitive performance attention testing
Subjective self-perceived capacity to be accurate on cognitive test
Time frame: 9 a.m. before cognitive performance attention testing
Balance
Time frame: 9 a.m. before cognitive performance attention testing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shona Halson, PhD principal investigator
Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trypophan, Theanine and 5'AMP in people with Sleep and Physical Performance, run by PepsiCo Global R&D at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (TST) (time frame: Time from sleep onset to 8:00 a.m.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.