MoodNCT05478980
The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function
A study testing Night Time Tea in people with Mood and Poor Quality Sleep, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood, Poor Quality Sleep, Good Sleep Habit
- What is being tested?
- Night Time Tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2021to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain Performance Nutrition Research Centre
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
About this study
Official title: 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.
Read the 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.
- Conditions
- Mood, Poor Quality Sleep, Good Sleep Habit, Sleep
- Being tested
- Night Time Tea, Control Tea
- Keywords
- Sleep, Mood, Physical health, Mental health, Immunological function
- Medical subject headings
- Sleep Hygiene, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night Time TeaDietary supplement
Night-time Tea
Control TeaDietary supplement
Feel New Tea
| Study group | Role | What they receive |
|---|---|---|
| Active Tea - Good Sleepers | Experimental | Not described Receives: Dietary Supplement: Night Time Tea |
| Control Tea - Good Sleepers | Active comparator | Not described Receives: Dietary Supplement: Control Tea |
| Active Tea - Poor Sleepers | Experimental | Not described Receives: Dietary Supplement: Night Time Tea |
| Control Tea - Poor Sleepers | Active comparator | Not described Receives: Dietary Supplement: Control Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus sleep diary (CSD) - Subjective sleep quality
Measured: Following 7 days of intervention
Secondary outcomes (20)
Consensus sleep diary (CSD) - Subjective sleep continuity (Total sleep time)
Measured: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Time in bed)
Measured: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep efficiency %)
Measured: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep latency)
Measured: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Number of awakenings and wake after sleep onset)
Measured: Following 7 days of intervention
Karolinska Sleepiness Scale (KSS)
Measured: Following 7 days of intervention
Positive and negative affect schedule (PANAS)
Measured: Following 7 days of intervention
World Health Organization Quality of Life- Brief (WHOQOL-BREF)
Measured: Following 7 days of intervention
Short-Form Health Survey 36 (SF-36)
Measured: Following 7 days of intervention
Actigraphy objective sleep measures (Time in bed)
Measured: Following 7 days of intervention
Actigraphy objective sleep measures (Total sleep time)
Measured: Following 7 days of intervention
Actigraphy objective sleep measures (Sleep efficiency %)
Measured: Following 7 days of intervention
Actigraphy objective sleep measures (Number of awakenings)
Measured: Following 7 days of intervention
Actigraphy objective sleep measures (Sleep latency)
Measured: Following 7 days of intervention
Actigraphy objective sleep measures (wake after sleep onset)
Measured: Following 7 days of intervention
Immunological markers (Interleukins-6)
Measured: Following 7 days of intervention
Immunological markers (Interleukins-10)
Measured: Following 7 days of intervention
Immunological markers (Tumour Necrosis Factor - alpha (TNF-a))
Measured: Following 7 days of intervention
Immunological markers (C-Reactive protein)
Measured: Following 7 days of intervention
Immunological markers (Cortisol)
Measured: Following 7 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start3 Nov 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiona Dodd, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478980
- Sponsor's protocol ID
- 50CE1
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function: a Randomised, Controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT05478980
- Acronym / sponsor ID
- 50CE1
- Conditions
- Mood, Poor Quality Sleep, Good Sleep Habit, Sleep
- Keywords
- Sleep, Mood, Physical health, Mental health, Immunological function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Tea - Good Sleepers | Experimental | Dietary Supplement: Night Time Tea |
| Control Tea - Good Sleepers | Active comparator | Dietary Supplement: Control Tea |
| Active Tea - Poor Sleepers | Experimental | Dietary Supplement: Night Time Tea |
| Control Tea - Poor Sleepers | Active comparator | Dietary Supplement: Control Tea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Night Time TeaNight-time Tea | Dietary supplement | Active Tea - Good Sleepers, Active Tea - Poor Sleepers |
| Control TeaFeel New Tea | Dietary supplement | Control Tea - Good Sleepers, Control Tea - Poor Sleepers |
Primary outcome
Consensus sleep diary (CSD) - Subjective sleep quality
Time frame: Following 7 days of intervention
20 secondary outcomes
Consensus sleep diary (CSD) - Subjective sleep continuity (Total sleep time)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Time in bed)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep efficiency %)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep latency)
Time frame: Following 7 days of intervention
Consensus sleep diary (CSD) - Subjective sleep continuity (Number of awakenings and wake after sleep onset)
Time frame: Following 7 days of intervention
Karolinska Sleepiness Scale (KSS)
Time frame: Following 7 days of intervention
Positive and negative affect schedule (PANAS)
Time frame: Following 7 days of intervention
World Health Organization Quality of Life- Brief (WHOQOL-BREF)
Time frame: Following 7 days of intervention
Short-Form Health Survey 36 (SF-36)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Time in bed)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Total sleep time)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Sleep efficiency %)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Number of awakenings)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (Sleep latency)
Time frame: Following 7 days of intervention
Actigraphy objective sleep measures (wake after sleep onset)
Time frame: Following 7 days of intervention
Immunological markers (Interleukins-6)
Time frame: Following 7 days of intervention
Immunological markers (Interleukins-10)
Time frame: Following 7 days of intervention
Immunological markers (Tumour Necrosis Factor - alpha (TNF-a))
Time frame: Following 7 days of intervention
Immunological markers (C-Reactive protein)
Time frame: Following 7 days of intervention
Immunological markers (Cortisol)
Time frame: Following 7 days of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Dodd principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night Time Tea in people with Mood and Poor Quality Sleep, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus sleep diary (CSD) - Subjective sleep quality (time frame: Following 7 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.