Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes

NCT ID: NCT05032729

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2022-08-09

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).

Conditions

Sleep; Physical Performance; Cognitive Performance; Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo beverage

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Higher tryptophan beverage

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

Group Type: EXPERIMENTAL

Trypophan, Theanine and 5'AMP

Intervention Type: OTHER

250 ml beverage consumed at 21:00 hours

Lower tryptophan beverage

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

Group Type: EXPERIMENTAL

Trypophan, Theanine and 5'AMP

Intervention Type: OTHER

250 ml beverage consumed at 21:00 hours

Interventions

Trypophan, Theanine and 5'AMP

250 ml beverage consumed at 21:00 hours

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shona Halson, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wayville, South Australia, Australia

Countries

Australia

Other Identifiers

PEP-1911

Identifier Type: -

Identifier Source: org_study_id