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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Tea - Good Sleepers | Experimental |
| |
| Control Tea - Good Sleepers | Active Comparator |
| |
| Active Tea - Poor Sleepers | Experimental |
| |
| Control Tea - Poor Sleepers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Night Time Tea | Dietary Supplement | Night-time Tea |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consensus sleep diary (CSD) - Subjective sleep quality | Following 7 days of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Consensus sleep diary (CSD) - Subjective sleep continuity (Total sleep time) | Following 7 days of intervention | |
| Consensus sleep diary (CSD) - Subjective sleep continuity (Time in bed) | Following 7 days of intervention |
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Inclusion Criteria:
Healthy male and female adults aged 18 years and above. Both good sleepers and poor sleepers will be recruited. 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.
Exclusion Criteria:
Both good and poor sleeper participants cannot participate if they display evidence of current or previous sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders); an initial screening for sleep disorders will be conducted using the Sleep Disorders Screening Checklist - 25 (SDS-CL).
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| Name | Affiliation | Role |
|---|---|---|
| Fiona Dodd | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Performance Nutrition Research Centre | Newcastle upon Tyne | Tyne & Wear | NE1 8ST | United Kingdom |
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| ID | Term |
|---|---|
| D000070263 | Sleep Hygiene |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| Control Tea | Dietary Supplement | Feel New Tea |
|
| Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep efficiency %) | Following 7 days of intervention |
| Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep latency) | Following 7 days of intervention |
| Consensus sleep diary (CSD) - Subjective sleep continuity (Number of awakenings and wake after sleep onset) | Following 7 days of intervention |
| Karolinska Sleepiness Scale (KSS) | Following 7 days of intervention |
| Positive and negative affect schedule (PANAS) | Following 7 days of intervention |
| World Health Organization Quality of Life- Brief (WHOQOL-BREF) | Following 7 days of intervention |
| Short-Form Health Survey 36 (SF-36) | Following 7 days of intervention |
| Actigraphy objective sleep measures (Time in bed) | Following 7 days of intervention |
| Actigraphy objective sleep measures (Total sleep time) | Following 7 days of intervention |
| Actigraphy objective sleep measures (Sleep efficiency %) | Following 7 days of intervention |
| Actigraphy objective sleep measures (Number of awakenings) | Following 7 days of intervention |
| Actigraphy objective sleep measures (Sleep latency) | Following 7 days of intervention |
| Actigraphy objective sleep measures (wake after sleep onset) | Following 7 days of intervention |
| Immunological markers (Interleukins-6) | Following 7 days of intervention |
| Immunological markers (Interleukins-10) | Following 7 days of intervention |
| Immunological markers (Tumour Necrosis Factor - alpha (TNF-a)) | Following 7 days of intervention |
| Immunological markers (C-Reactive protein) | Following 7 days of intervention |
| Immunological markers (Cortisol) | Following 7 days of intervention |