Effect of pre-sleep alpha-lactalbumin supplementation in a trained population with sleep difficulties

Phase 4

Recruiting

• Conditions: Sleep difficulty; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621001611819
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-26
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Inclusion: Participants must be between 18-40 years old, and currently be completing structured moderate-vigorous exercise at least three times per week for a minimum total of five hours per week to meet trained athlete” guidelines. Further, participants will be screened using the Athlete Sleep Screening Questionnaire (Appendix 1) and Pittsburgh Sleep Quality Index (Appendix 2), and those with a sleep difficulty score equal to or greater than 5, global PSQI score >5 and a sleep onset latency >15 minutes will be eligible. These scores coincide with equal to or greater than mild sleep difficulty and poor-quality sleep, which are the targeted participants for this study.

Female participants are required to be naturally menstruating or taking an oral contraceptive pill. As female hormone differences across the menstrual cycle can influence sleep, participation will occur during predictable phases where the influence of hormones is low.

Exclusion Criteria

Exclusion: smoking, excessive alcohol consumption (>17 standard drinks per week), dairy allergy, high caffeine use (e.g., >5 mg·kg-1·d-1), antidepressant or sleep medication use, current or recently finished night shift work, recent transmeridian travel, fluctuating bedtimes, and pregnancy. These exclusions criteria relate to confounding influences that may affect sleep or the plasma TRP:LNAA ratio.

Study & Design

• Study Type: Interventional
• Study Design: Not specified