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Completed

NCT Number: NCT05032729

Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

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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Key information

Conditions

Sleep Balance Behavior Cognitive Performance Motor Activity Physical Performance

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus

Wayville, South Australia, 5034, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trypophan, Theanine and 5'AMP

Other

250 ml beverage consumed at 21:00 hours

Placebo

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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