Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

PepsiCo

Status: Completed

Conditions: Balance; Physical Performance; Cognitive Performance; Sleep

Treatments: Other: Placebo; Other: Trypophan, Theanine and 5'AMP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05032729

PEP-1911

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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19 participants in 3 patient groups, including a placebo group

Placebo beverage

Placebo Comparator group

Description:

* Flavor * Non-nutritive sweetener * Color added to match whey appearance

Treatment:

Other: Placebo

Higher tryptophan beverage

Experimental group

Description:

* 2.7g high Glycemic Index Carbohydrate * 40g whey * 0.855g tryptophan * 660mg theanine * 53mcg 5'AMP * Non-nutritive sweetener * Flavor

Treatment:

Other: Trypophan, Theanine and 5'AMP

Lower tryptophan beverage

Experimental group

Description:

* 2.7g high Glycemic Index Carbohydrate * 30g whey * 0.641g tryptophan * 660mg theanine * 53mcg 5'AMP * Non-nutritive sweetener * Flavor

Treatment:

Other: Trypophan, Theanine and 5'AMP