The effect of green tea amino acid L-Theanine formulation on markers of stress and quality of sleep (THESLeep Project)

Not Applicable

Completed

• Conditions: Anxiety; Mental Health - Anxiety; Alternative and Complementary Medicine - Other alternative and complementary medicine; Neurological - Other neurological disorders; Quality of sleep

• Registration Number: ACTRN12623000776606
• Lead Sponsor: niversity of Canberra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-17
• Study Completion: 2024-08-02
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Healthy participants with mild to moderate sleep disturbances that score greater or equal to 5 on the Pittsburgh Sleep Quality Index (PSQI) questionnaire.

Exclusion Criteria

Smokers, known cardiovascular, hepatic, gastrointestinal, renal, malignant, neurological, degenerative illnesses, suffer from diabetes (type 1 and type 2), are pregnant or lactating. Suffer from clinical sleep disorders (obstructive sleep apnoea), are shift workers or have completed trans-meridian travel within the previous month. Taking medication or herbal supplements for sleep, or taking antipsychotic or hypnotic medication. Adults older than 65 years as well as children and adolescents are also excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep onset latency (Measured using Motionwatch 8 Actigraphy device)[ Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)];Pittsburgh Sleep Quality Index (PSQI)[ Administered at screening, baseline (Week 1 post-screening), start of the treatment (Week 2 post-screening), end of the treatment (Week 3 post-screening) and two week post completion follow up.];The Consensus Sleep Diary (15 item)[ Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)]