Brain Performance Nutrition Research Centre
Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom
NCT Number: NCT05478980
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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).
Night-time Tea
Feel New Tea
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Time frame: Following 7 days of intervention
Northumbria University
Other
The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function: a Randomised, Controlled, Crossover Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07699588
Behavior, Loneliness
New York, United States
View Trial DetailsNCT06406946
Anxiety, Anxiety Disorders
Newcastle upon Tyne, Tyne and Wear, United Kingdom
View Trial DetailsNCT06107075
Behavior, Cognitive Change
Newcastle upon Tyne, United Kingdom
View Trial DetailsNCT06465680
Behavior, Behavioral Symptoms
Ann Arbor, Michigan, United States
View Trial Details