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Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

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ClinicalTrials.gov Identifier: NCT05032729
Recruitment Status : Not yet recruiting
First Posted : September 2, 2021
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

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).


Condition or disease Intervention/treatment Phase
Sleep Physical Performance Cognitive Performance Balance Other: Trypophan, Theanine and 5'AMP Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
Estimated Study Start Date : November 6, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Arm Intervention/treatment
Placebo Comparator: Placebo beverage
  • Flavor
  • Non-nutritive sweetener
  • Color added to match whey appearance
Other: Placebo
250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages

Experimental: Higher tryptophan beverage
  • 2.7g high Glycemic Index Carbohydrate
  • 40g whey
  • 0.855g tryptophan
  • 660mg theanine
  • 53mcg 5'AMP
  • Non-nutritive sweetener
  • Flavor
Other: Trypophan, Theanine and 5'AMP
250 ml beverage consumed at 21:00 hours

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




Primary Outcome Measures :
  1. Total Sleep Time (TST) [ Time Frame: Time from sleep onset to 8:00 a.m. ]
    Measured in minutes during polysomnography. Longer is better.

  2. 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.

  3. 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

  4. Sleep Onset Latency (SOL) [ Time Frame: Transition from wakefulness to sleep ]
    Measured in minutes during polysomnography. Shorter time to onset is better.

  5. Rapid Eye Movement (REM) Latency [ Time Frame: From sleep onset to REM sleep ]
    Measured in minutes during polysomnography. Shorter time to REM is better.

  6. 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.

  7. 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.

  8. Arousals [ Time Frame: From sleep onset to 8 a.m. ]
    Measured as a count during polysomnography. Less arousals are better.

  9. Awakenings [ Time Frame: From sleep onset to 8 a.m. ]
    Measured as a count during polysomnography. Less awakenings are better.

  10. Stage shifts [ Time Frame: From sleep onset to 8 a.m. ]
    Measured as a count during polysomnography. Normal amount of stage shifts are better.

  11. 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.

  12. (Subjective) Perceived Sleep Quality [ Time Frame: 08:30 a.m. following polysomnography ]
    Rated from 1 (very good) to 5 (poor). Lower number is better.

  13. (Subjective) Sleep Quantity [ Time Frame: 08:30 a.m. following polysomnography ]
    Measured in hours and minutes. Higher number is better.

  14. (Subjective) Sleep Onset Latency [ Time Frame: 08:30 a.m. following polysomnography ]
    Measured in hours and minutes. Lower number is better.


Secondary Outcome Measures :
  1. Exercise performance: power output [ Time Frame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m. ]
    Cycle ergometer to measure power output in watts, with instructions to give maximal effort. Higher watts are better.

  2. Exercise performance: perceived exertion [ Time Frame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m. ]
    Rating of perceived exertion (RPE) on a scale of 6 (lower) to 20 (higher) intensity levels.

  3. Exercise performance: heart rate [ Time Frame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m. ]
    Measured in beats per minute (bpm) by heart rate monitor

  4. Cognitive performance: sustained attention [ Time Frame: 10 minute testing period at 9 a.m. Higher performance is better. ]
    Psychomotor vigilance reaction time task (PVT-192) handheld ambulatory monitoring

  5. Subjective alertness [ Time Frame: 9 a.m. before cognitive performance attention testing. ]
    Rated on visual analog scale from 0 (feeling not at all alert) to 100 (feeling completely alert). Feeling more alert is better.

  6. Subjective self-perceived capacity to be fast on cognitive test [ Time Frame: 9 a.m. before cognitive performance attention testing ]
    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.

  7. Subjective self-perceived capacity to be accurate on cognitive test [ Time Frame: 9 a.m. before cognitive performance attention testing ]
    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.

  8. Balance [ Time Frame: 9 a.m. before cognitive performance attention testing. ]
    Postural sway area 95cm/2 measured by computerized force platform. Less sway is better.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological males due to the influence that menstrual cycle may have on sleep and the study aims to investigate previous findings involving male only participants
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032729


Contacts
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Contact: Shona Halson, PhD +61 422224491 shona.halson@acu.edu.au

Locations
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Australia, South Australia
Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus
Wayville, South Australia, Australia, 5034
Contact: Charli Sargent, PhD    +61 08 8378 4516    charli.sargent@cqu.edu.au   
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Shona Halson, PhD Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT05032729    
Other Study ID Numbers: PEP-1911
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PepsiCo Global R&D:
nutrition
sleep
polysomnography
performance
exercise