The aim of the study is to determine whether a night-time tea can improve subjective sleep quality in healthy sleepers and self-reported poor sleepers, compared to a control drink.
The study will adopt a randomised, double-blind, placebo controlled, crossover design. Sixty-eight healthy adults aged 18+ (34 good sleepers and 34 poor sleepers) will be recruited from the general population. Good sleepers will be recruited if they have a stable sleep-wake schedule (i.e. bed/wake time within the range of 22.00 - 09.00 and with at least 6.5 hours of sleep duration reported per night). Poor sleepers will be recruited if they report subjective sleep difficulties (i.e. poor sleep quality or unrefreshing sleep) and if they display a Pittsburgh Sleep Quality Index total score of \>5. Participants will consume both an active tea, and a control tea in a counterbalanced order for 7 days (separated by a 7-day washout period). Participants will complete questionnaires assessing mood, quality of life and sleep and provide blood samples to assess immunological markers. Sleep monitoring will also be conducted using actigraphy sleep monitoring and sleep diaries. Assessments will be made at baseline and following 7 days supplementation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
78
Night-time Tea
Feel New Tea
Brain Performance Nutrition Research Centre
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Consensus sleep diary (CSD) - Subjective sleep quality
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Total sleep time)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Time in bed)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep efficiency %)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep latency)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Number of awakenings and wake after sleep onset)
Time frame: Following 7 days of intervention
Karolinska Sleepiness Scale (KSS)
Time frame: Following 7 days of intervention
Positive and negative affect schedule (PANAS)
Time frame: Following 7 days of intervention
World Health Organization Quality of Life- Brief (WHOQOL-BREF)
Time frame: Following 7 days of intervention
Short-Form Health Survey 36 (SF-36)
Time frame: Following 7 days of intervention
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Actigraphy objective sleep measures (Time in bed)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Total sleep time)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Sleep efficiency %)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Number of awakenings)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Sleep latency)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (wake after sleep onset)
Time frame: Following 7 days of intervention
Immunological markers (Interleukins-6)
Time frame: Following 7 days of intervention
Immunological markers (Interleukins-10)
Time frame: Following 7 days of intervention
Immunological markers (Tumour Necrosis Factor - alpha (TNF-a))
Time frame: Following 7 days of intervention
Immunological markers (C-Reactive protein)
Time frame: Following 7 days of intervention
Immunological markers (Cortisol)
Time frame: Following 7 days of intervention