Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

Study Overview
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Brief Summary
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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).

Official Title
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Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

Conditions
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Sleep, Physical Performance, Cognitive Performance, Balance

Intervention / Treatment
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* Other: Trypophan, Theanine and 5'AMP
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo beverage<br>Flavor Non-nutritive sweetener Color added to match whey appearance | Other: Placebo<br>* 250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages<br>|
| Experimental: Higher tryptophan beverage<br>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<br>* 250 ml beverage consumed at 21:00 hours<br>|
| Experimental: Lower tryptophan beverage<br>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<br>* 250 ml beverage consumed at 21:00 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time (TST) | Measured in minutes during polysomnography. Longer is better. | 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. | 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 | From sleep onset to 8:00 a.m. | 
| Sleep Onset Latency (SOL) | Measured in minutes during polysomnography. Shorter time to onset is better. | Transition from wakefulness to sleep | 
| Rapid Eye Movement (REM) Latency | Measured in minutes during polysomnography. Shorter time to REM is better. | From sleep onset to REM sleep | 
| Sleep stage 3 Latency | Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better. | From sleep onset to deep sleep | 
| Sleep stage 1, 2, 3 AND REM | Measured in minutes during polysomnography. Normal stage pattern is better. | Measured continuously throughout the night from sleep onset to 8 a.m. | 
| Arousals | Measured as a count during polysomnography. Less arousals are better. | From sleep onset to 8 a.m. | 
| Awakenings | Measured as a count during polysomnography. Less awakenings are better. | From sleep onset to 8 a.m. | 
| Stage shifts | Measured as a count during polysomnography. Normal amount of stage shifts are better. | 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. | 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. | 08:30 a.m. following polysomnography | 
| (Subjective) Sleep Quantity | Measured in hours and minutes. Higher number is better. | 08:30 a.m. following polysomnography | 
| (Subjective) Sleep Onset Latency | Measured in hours and minutes. Lower number is better. | 08:30 a.m. following polysomnography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise performance: power output | Cycle ergometer to measure power output in watts, with instructions to give maximal effort. Higher watts are better. | 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. | 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 | 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 | 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. | 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. | 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. | 9 a.m. before cognitive performance attention testing | 
| Balance | Postural sway area 95cm/2 measured by computerized force platform. Less sway is better. | 9 a.m. before cognitive performance attention testing. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, sleep, polysomnography, performance, exercise