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Completed

NCT Number: NCT05478980

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Performance Nutrition Research Centre

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

About this study

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.

Who can participate

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).

  • 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

Treatment and study plan

Night Time Tea

Dietary Supplement

Night-time Tea

Control Tea

Dietary Supplement

Feel New Tea

Primary outcomes

  1. Consensus sleep diary (CSD) - Subjective sleep quality

    Time frame: Following 7 days of intervention

Secondary outcomes

  1. Consensus sleep diary (CSD) - Subjective sleep continuity (Total sleep time)

    Time frame: Following 7 days of intervention

  2. Consensus sleep diary (CSD) - Subjective sleep continuity (Time in bed)

    Time frame: Following 7 days of intervention

  3. Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep efficiency %)

    Time frame: Following 7 days of intervention

  4. Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep latency)

    Time frame: Following 7 days of intervention

  5. Consensus sleep diary (CSD) - Subjective sleep continuity (Number of awakenings and wake after sleep onset)

    Time frame: Following 7 days of intervention

  6. Karolinska Sleepiness Scale (KSS)

    Time frame: Following 7 days of intervention

  7. Positive and negative affect schedule (PANAS)

    Time frame: Following 7 days of intervention

  8. World Health Organization Quality of Life- Brief (WHOQOL-BREF)

    Time frame: Following 7 days of intervention

  9. Short-Form Health Survey 36 (SF-36)

    Time frame: Following 7 days of intervention

  10. Actigraphy objective sleep measures (Time in bed)

    Time frame: Following 7 days of intervention

  11. Actigraphy objective sleep measures (Total sleep time)

    Time frame: Following 7 days of intervention

  12. Actigraphy objective sleep measures (Sleep efficiency %)

    Time frame: Following 7 days of intervention

  13. Actigraphy objective sleep measures (Number of awakenings)

    Time frame: Following 7 days of intervention

  14. Actigraphy objective sleep measures (Sleep latency)

    Time frame: Following 7 days of intervention

  15. Actigraphy objective sleep measures (wake after sleep onset)

    Time frame: Following 7 days of intervention

  16. Immunological markers (Interleukins-6)

    Time frame: Following 7 days of intervention

  17. Immunological markers (Interleukins-10)

    Time frame: Following 7 days of intervention

  18. Immunological markers (Tumour Necrosis Factor - alpha (TNF-a))

    Time frame: Following 7 days of intervention

  19. Immunological markers (C-Reactive protein)

    Time frame: Following 7 days of intervention

  20. Immunological markers (Cortisol)

    Time frame: Following 7 days of intervention

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2022
Registry last updated
Oct 12, 2022

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.

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