Clinical trial NCT05032729: Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
Official title: Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Physical Performance
Cognitive Performance
Balance
Keywords: nutrition
sleep
polysomnography
performance
exercise
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


Eligibility 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

Primary outcomes:
measure: Total Sleep Time (TST)
timeFrame: Time from sleep onset to 8:00 a.m.
measure: Wake After Sleep Onset (WASO)
timeFrame: From sleep onset till 8:00 a.m.
measure: Sleep Efficiency (SE)
timeFrame: From sleep onset to 8:00 a.m.
measure: Sleep Onset Latency (SOL)
timeFrame: Transition from wakefulness to sleep
measure: Rapid Eye Movement (REM) Latency
timeFrame: From sleep onset to REM sleep
measure: Sleep stage 3 Latency
timeFrame: From sleep onset to deep sleep
measure: Sleep stage 1, 2, 3 AND REM
timeFrame: Measured continuously throughout the night from sleep onset to 8 a.m.
measure: Arousals
timeFrame: From sleep onset to 8 a.m.
measure: Awakenings
timeFrame: From sleep onset to 8 a.m.
measure: Stage shifts
timeFrame: From sleep onset to 8 a.m.
measure: Subjective Karolinska Sleepiness Scale (KSS)
timeFrame: Every thirty minutes from 20:00 p.m. until 22:30 p.m.
measure: (Subjective) Perceived Sleep Quality
timeFrame: 08:30 a.m. following polysomnography
measure: (Subjective) Sleep Quantity
timeFrame: 08:30 a.m. following polysomnography
measure: (Subjective) Sleep Onset Latency
timeFrame: 08:30 a.m. following polysomnography
Secondary outcomes:
measure: Exercise performance: power output
timeFrame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
measure: Exercise performance: perceived exertion
timeFrame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
measure: Exercise performance: heart rate
timeFrame: During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.
measure: Cognitive performance: sustained attention
timeFrame: 10 minute testing period at 9 a.m. Higher performance is better.
measure: Subjective alertness
timeFrame: 9 a.m. before cognitive performance attention testing.
measure: Subjective self-perceived capacity to be fast on cognitive test
timeFrame: 9 a.m. before cognitive performance attention testing
measure: Subjective self-perceived capacity to be accurate on cognitive test
timeFrame: 9 a.m. before cognitive performance attention testing
measure: Balance
timeFrame: 9 a.m. before cognitive performance attention testing.
Other outcomes:
Locations:
city: Wayville
country: Australia
facility: Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus
state: South Australia
Study officials:
affiliation: Appleton Institute CQUniversity, School of Medical, Health, and Applied Sciences, Adelaide Campus and Australian Catholic University
name: Shona Halson, PhD
role: PRINCIPAL_INVESTIGATOR
References: