None listed
Conditions
Brief summary
The study will assess the effects of different doses of green tea amino acid L-Theanine supplement (placebo, 100mg, 200mg and 400mg) in healthy individuals with mild to moderate sleep disturbances. It is hypothesized that the consumption of L-Theanine supplement will improve the quality of sleep via the improvements in markers associated with stress. This study is a 3 week (1 week baseline and 2 weeks intervention), double-blinded, placebo controlled, four-arm, parallel pilot trial.
Interventions
All enrolled participants will be allocated into one of the three treatment groups or into the control group. After one week baseline measurements, participants in the treatment groups will be provided with the L-theanine sachet for period of two weeks containing, flavoring and effervescent powder and 100, 200 or 400mg of L-theanine. Participants will be asked to consume the content of the sachet by dissolving it in the water (around 125 ml) one hour before bedtime every evening for 14 days.
Pa
All enrolled participants will be allocated into one of the three treatment groups or into the control group. After one week baseline measurements, participants in the treatment groups will be provided with the L-theanine sachet for period of two weeks containing, flavoring and effervescent powder and 100, 200 or 400mg of L-theanine. Participants will be asked to consume the content of the sachet by dissolving it in the water (around 125 ml) one hour before bedtime every evening for 14 days. Participants will be asked to return their supplement at the end of the treatment period. Unused sachets will be counted to determine the compliance.
Sponsors
University of Canberra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Outcome results
None listed