The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function

Northumbria University

Status: Completed

Conditions: Good Sleep Habit; Poor Quality Sleep; Mood; Sleep

Treatments: Dietary Supplement: Control Tea; Dietary Supplement: Night Time Tea

Study type: Interventional

Funder types: Other

Identifiers

NCT05478980

50CE1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

• Participants must not be shift workers
• Cannot currently be participating in other research trials which will compromise the results here
• Participants cannot take part if they will be sleeping at a location other than their usual residence during participation
• Nor if they have experienced travel across multiple time zones within the last three months or will be experiencing travel across multiple time zones during the study
• Participants cannot take part if they have current or previous mood disturbances
• Are currently unwell with anything that impacts sleep
• Are currently using medication which affects the central nervous system
• Or are currently misusing alcohol or drugs

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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78 participants in 4 patient groups

Active Tea - Good Sleepers

Experimental group

Treatment:

Dietary Supplement: Night Time Tea

Control Tea - Good Sleepers

Active Comparator group

Treatment:

Dietary Supplement: Control Tea

Active Tea - Poor Sleepers

Experimental group

Treatment:

Dietary Supplement: Night Time Tea

Control Tea - Poor Sleepers

Active Comparator group

Treatment:

Dietary Supplement: Control Tea