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

The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function: a Randomised, Controlled, Crossover Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Mood; Poor Quality Sleep; Good Sleep Habit
• Intervention / Treatment: Dietary supplement: Night Time Tea; Dietary supplement: Control Tea

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne & Wear
    • Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
      • Brain Performance Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Tea - Good Sleepers	Dietary supplement: Night Time Tea; Night-time Tea
Active Comparator: Control Tea - Good Sleepers	Dietary supplement: Control Tea; Feel New Tea
Experimental: Active Tea - Poor Sleepers	Dietary supplement: Night Time Tea; Night-time Tea
Active Comparator: Control Tea - Poor Sleepers	Dietary supplement: Control Tea; Feel New Tea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Consensus sleep diary (CSD) - Subjective sleep quality	Following 7 days of intervention

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Northumbria University
• Investigators: Principal Investigator: Fiona Dodd, Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Sleep; Mental health; Mood; Immunological function; Physical health
• Other Study ID Numbers: 50CE1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No