SleepNCT05239845
Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress
A study testing Prebiotic in people with Sleep, run by Northumbria University at 2 sites in United Kingdom.
Trial summary
The aim of the proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Mar 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must self-assess themselves as being in good health.
- Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week)
- Aged 25 to 60 years at the time of randomisation
- Fluent in English
- Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of >5 on the Pittsburgh Sleep Quality Index (PSQI).
Who cannot join
- Member of own household currently participating in this trial
- Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
- History of seizures or epilepsy
- Shift working or have a history of shift work within the previous six months
- Currently, or within the previous 8 weeks, consuming any prebiotic or probiotic products/supplements (including specifically oligosaccharides)
- Participation in any other intervention research trials
Show all 15Show fewer
- Sleeping at a location other than their usual residence more than two nights per week during participation
- Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study
- Current or recent mood disturbances or Axis I disorders
- Current misuse of alcohol and/or drugs
- Current smoker
- Recent (within the last 12 weeks) infection and/or use of antibiotic medication
- Pregnant, seeking to become pregnant or lactating
- Those using (including within the last 2 weeks) proton-pump inhibitors
- Milk allergy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Northumbria Sleep Research, Northumbria University
Newcastle
Northumbria University
Newcastle
About this study
Official title: Evaluating the Effects of Prebiotic-based Interventions on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress Following 56 Days Consumption in Healthy Volunteers
The aim of the proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting poor sleep quality.
- Conditions
- Sleep
- Being tested
- Prebiotic, Control
- Keywords
- Gut Microbiome, Stress, Immune Function, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
The bioactive ingredients used in this study include bovine milk fat globule membrane (MFGM), bovine lactoferrin and a prebiotic blend of polydextrose and galactooligosaccharides (PDX/GOS).
ControlOther
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Investigational Supplement 1 (INV-1) | Active comparator | The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. Receives: Dietary Supplement: Prebiotic |
| Investigational Supplement 1 (INV-2) | Active comparator | The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. Receives: Dietary Supplement: Prebiotic |
| Investigational Supplement 1 (INV-3) | Active comparator | The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. Receives: Dietary Supplement: Prebiotic |
| Control | Placebo comparator | The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lab-recorded polysomnography- Sleep Quality
percentage of time in staged sleep from total sleep recorded time
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Secondary outcomes (45)
Lab-recorded polysomnography- Sleep onset latency
minutes taken from intention to sleep to first epoch of any stage of sleep
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Total sleep time
minutes of staged sleep over entire sleep duration period
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Number of awakenings
number of <15 second bouts of Wake surrounded, at both ends, by any sleep stage
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Wake after sleep onset
cumulative minutes of scored Wake during entire sleep duration following sleep initiation
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Time spent in stages of rapid eye movement (REM) and non-REM sleep
percentage of time spent in REM, N1, N2, N3
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- REM Rebound
length, frequency and depth of REM sleep
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Sleep microstructure
including k-complexes - >.0.5 secs. negative then positive wave and fast/slow sleep spindles - >.0.5 secs. sinusoidal waves 11-16Hz
Measured: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Actigraphy - Sleep onset latency
recorded minutes taken from intention to sleep to sleep initiation
Measured: Change from baseline following 56 days of supplement consumption
Actigraphy - Total sleep time
recorded minutes asleep over entire sleep period
Measured: Change from baseline following 56 days of supplement consumption
Actigraphy - Number of awakenings
recorded number of awakenings during entire sleep period
Measured: Change from baseline following 56 days of supplement consumption
Actigraphy - Wake after sleep onset (WASO)
recorded minutes awake during the entire sleep period following sleep onset
Measured: Change from baseline following 56 days of supplement consumption
Actigraphy - Sleep efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Measured: Change from baseline following 56 days of supplement consumption
Blood Pressure and Heart Rate (BP/HR)
Measured using a fully automatic oscillometric device
Measured: Change from baseline following 56 days of supplement consumption
Body Mass Index (BMI)
calculated using standard formula: weight (kg) / [height (m)]2
Measured: Change from baseline following 56 days of supplement consumption
Waist-to-Hip Ratio (WHR)
WHR will be calculated by dividing waist circumference by hip circumference.
Measured: Change from baseline following 56 days of supplement consumption
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI): Total Score. The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality.
Measured: Change from baseline following 56 days of supplement consumption
Profile of Mood States (POMS)
Profile of Mood States (POMS): Mood scores. The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. 65 adjectives rated on 5-point scale 0= not at all; 1=a little; 2=moderately; 3=quite a bit; 4=extremely. Factor analysis: 6 subscales tension-anxiety (9 items, score range: 0-36) depression (15 items, range 0-60) anger-hostility (12 items, range 0-48) vigor-activity (8 items, range 0-32) fatigue (7 items, range 0-28) confusion-bewilderment (7 items, range 0-28) Total mood disturbance (TMD): (range 0-200)
Measured: Change from baseline following 56 days of supplement consumption
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
A 21-item measure of mood over the previous week (each item is rated on scale from 0-3). Scoring creates 3 component scores: depression, anxiety and stress (each on a scale of 0-21) with higher scores indicating higher symptomology. Cut-off scores, according to each set of symptoms, are available (normal, mild, moderate, severe and extremely severe) or total scores can be derived by multiplying the sum of all three component scores by 2.
Measured: Change from baseline following 56 days of supplement consumption
State-Trait Anxiety Inventory (STAI)
A 40-item measure of current and general anxiety levels. Each item is rated on a scale from 1-4. Scoring creates two components: state anxiety (20 items) and trait anxiety (20 items), with a range for each between 20-80. Following transformation through reversed coding, higher scores indicate higher levels of anxiety.
Measured: Change from baseline following 56 days of supplement consumption
Work Productivity and Activity Impairment questionnaire (WPAI)
A 6-item measure of the impact of an individual's health on their work over the previous week. There are 4 component scores: presenteeism, activity impairment, absenteeism and overall work productivity. All items have varying response formats and higher scores indicate more impairment in each domain. Overall scores can also be summed and multiplied by 100 for an overall impairment index.
Measured: Change from baseline following 56 days of supplement consumption
12-Item Short Form Survey (SF-12)
A 12-item measure of current perceptions of health status. All items have varying response formats and result in 8 component scores: 1) Limitations in physical activities because of health problems, 2) Limitations in social activities because of physical or emotional problems, 3) Limitations in usual role activities because of physical health problems, 4) Bodily pain, 5) General mental health (psychological distress and well-being), 6) Limitations in usual role activities because of emotional problems, 7) Vitality (energy and fatigue) and 8) General health perceptions.
Measured: Change from baseline following 56 days of supplement consumption
Perceived Stress Scale (PSS
Perceived Stress Scale (PSS): Total Score. The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress
Measured: Change from baseline following 56 days of supplement consumption
Gastrointestinal symptoms questionnaire
This in-house developed questionnaire is to be completed at the start and end of the trial, during the baseline and chronic lab visits respectively. When completing the assessment, participants will answer in relation to their experiences in the previous 7 days. The questionnaire asks 11 questions, plus a 12th open-ended question, about gastrointestinal experiences, with 5 possible ratings; 'not at all' (score of 0), 'A little' (score of 1), 'a moderate amount' (score of 2), 'quite a lot' (score of 3) and 'a severe amount' (score of 4). Scores can range between 0-44 with a higher score indicating a more negative experience of symptoms
Measured: Change from baseline following 56 days of supplement consumption
Sleep Diary -Total Sleep Time
how long, in minutes, the individual reports being asleep during the night between initiation and termination of sleep, accounting for nocturnal wake periods
Measured: Change from baseline following 56 days of supplement consumption
Sleep Diary -Time in bed
how long, in minutes, the individual reports being in bed intending to sleep
Measured: Change from baseline following 56 days of supplement consumption
Sleep Diary -Sleep Latency
how long, in minutes, the individual felt it took them to fall asleep after intending to sleep
Measured: Change from baseline following 56 days of supplement consumption
Sleep Diary -Number of Awakenings
number of perceived awakenings over the sleep period
Measured: Change from baseline following 56 days of supplement consumption
Sleep Diary - Wake After Sleep Onset (WASO)
how long, in minutes, the individual reports being awake during the night after sleep initiation
Measured: Change from baseline following 56 days of supplement consumption
Sleep Diary - Sleep Efficiency
Total Sleep Time divided by Time in Bed x 100, expressed as a percentage
Measured: Change from baseline following 56 days of supplement consumption
Sleep Diary - Sleep Quality
4 items (each scored on a 0-4 scale) covering nocturnal physical and psychological tension, sleep enjoyment and feelings of restedness. Items can be summed (range 0-16) with higher scores indicating poorer sleep quality.
Measured: Change from baseline following 56 days of supplement consumption
Dietary assessment- Intake24
The Intake 24 measure (https://intake24.co.uk/) will assess participants dietary recall over the previous 24 hour period. The generated results provide an indication of overall calorie intake as well as fibre, sugar, calcium, total fat, saturated fat, vitamin C, iron, folate, fruit and vegetable and red meat intake.
Measured: Change from baseline following 56 days of supplement consumption
Perceived sleep quality (VAS)
Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')
Measured: Change from baseline following 56 days of supplement consumption
Subjective Stress (VAS)
Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')
Measured: Change from baseline following 56 days of supplement consumption
Subjective mood (VAS)
Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')
Measured: Change from baseline following 56 days of supplement consumption
Subjective productivity (VAS)
Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')
Measured: Change from baseline following 56 days of supplement consumption
COMPASS global performance measures
Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Measured: Change from baseline following 56 days of supplement consumption
Cognitive domain factor score
Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Measured: Change from baseline following 56 days of supplement consumption
Cognitive Function under stressful conditions
Cognitive performance (multi tasking using Serial Subtractions (3s, 7s, 17s) and tracking simultaneously) during acute stress as a consequence of theOBSERVED MULTITASKING STRESSOR (OMS)
Measured: Change from baseline following 56 days of supplement consumption
Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)
Subjective stress will be measured via the state, trait anxiety inventory before and after each completion of the observed multitasking stressor (OMS)
Measured: Change from baseline following 56 days of supplement consumption
Changes in objective stress; as assessed by salivary cortisol levels
Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary cortisol levels between pre- and post-OMS
Measured: Change from baseline following 56 days of supplement consumption
Changes in objective stress; as assessed by salivary alpha-amylase levels
Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary cortisol levels between pre- and post-OMS
Measured: Change from baseline following 56 days of supplement consumption
Changes in objective stress; as assessed by galvanic skin response (GSR)
Galvanic skin response (GSR) will be recorded throughout the observed multitasking stressor (OMS)
Measured: Change from baseline following 56 days of supplement consumption
Changes in objective stress; as assessed by heart rate (HR)
Heart rate (HR) will be recorded throughout the observed multitasking stressor (OMS)
Measured: Change from baseline following 56 days of supplement consumption
Gut microbiome assessments (gut bacterial profile)
Assessed via analysis of self collected stool samples at baseline, during active supplementation and after 56 days of supplementation.
Measured: Change from baseline following 56 days of supplement consumption
Immunological marker Assessment -Blood
Immune function (identification of blood biomarkers of immune function in samples collected at baseline and chronic lab visits)
Measured: Change from baseline following 56 days of supplement consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start3 Mar 2022
- Primary completion28 Jun 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Reckitt Benckiser Group PLC
- Responsible party
- Sponsor
- Investigators
- Jason Ellis, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239845
- Sponsor's protocol ID
- 35654
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Prebiotic-based Interventions on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress Following 56 Days Consumption in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05239845
- Acronym / sponsor ID
- 35654
- Conditions
- Sleep
- Keywords
- Gut Microbiome, Stress, Immune Function, Cognition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Reckitt Benckiser Group PLC
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Feb 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 proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting poor sleep quality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Investigational Supplement 1 (INV-1) | Active comparator | Dietary Supplement: PrebioticThe total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. |
| Investigational Supplement 1 (INV-2) | Active comparator | Dietary Supplement: PrebioticThe total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. |
| Investigational Supplement 1 (INV-3) | Active comparator | Dietary Supplement: PrebioticThe total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. |
| Control | Placebo comparator | Other: ControlThe total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must self-assess themselves as being in good health.
- Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week)
- Aged 25 to 60 years at the time of randomisation
- Fluent in English
- Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of >5 on the Pittsburgh Sleep Quality Index (PSQI).
Key exclusion criteria (15 listed)
- Member of own household currently participating in this trial
- Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
- History of seizures or epilepsy
- Shift working or have a history of shift work within the previous six months
- Currently, or within the previous 8 weeks, consuming any prebiotic or probiotic products/supplements (including specifically oligosaccharides)
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 |
|---|---|---|
| PrebioticThe bioactive ingredients used in this study include bovine milk fat globule membrane (MFGM), bovine lactoferrin and a prebiotic blend of polydextrose and galactooligosaccharides (PDX/GOS). | Dietary supplement | Investigational Supplement 1 (INV-1), Investigational Supplement 1 (INV-2), Investigational Supplement 1 (INV-3) |
| ControlMaltodextrin | Other | Control |
Primary outcome
Lab-recorded polysomnography- Sleep Quality
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
percentage of time in staged sleep from total sleep recorded time
45 secondary outcomes
Lab-recorded polysomnography- Sleep onset latency
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Total sleep time
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Number of awakenings
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Wake after sleep onset
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Time spent in stages of rapid eye movement (REM) and non-REM sleep
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- REM Rebound
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Sleep microstructure
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Actigraphy - Sleep onset latency
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Total sleep time
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Number of awakenings
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Wake after sleep onset (WASO)
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Sleep efficiency
Time frame: Change from baseline following 56 days of supplement consumption
Blood Pressure and Heart Rate (BP/HR)
Time frame: Change from baseline following 56 days of supplement consumption
Body Mass Index (BMI)
Time frame: Change from baseline following 56 days of supplement consumption
Waist-to-Hip Ratio (WHR)
Time frame: Change from baseline following 56 days of supplement consumption
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline following 56 days of supplement consumption
Profile of Mood States (POMS)
Time frame: Change from baseline following 56 days of supplement consumption
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: Change from baseline following 56 days of supplement consumption
State-Trait Anxiety Inventory (STAI)
Time frame: Change from baseline following 56 days of supplement consumption
Work Productivity and Activity Impairment questionnaire (WPAI)
Time frame: Change from baseline following 56 days of supplement consumption
12-Item Short Form Survey (SF-12)
Time frame: Change from baseline following 56 days of supplement consumption
Perceived Stress Scale (PSS
Time frame: Change from baseline following 56 days of supplement consumption
Gastrointestinal symptoms questionnaire
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary -Total Sleep Time
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary -Time in bed
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary -Sleep Latency
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary -Number of Awakenings
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary - Wake After Sleep Onset (WASO)
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary - Sleep Efficiency
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary - Sleep Quality
Time frame: Change from baseline following 56 days of supplement consumption
Dietary assessment- Intake24
Time frame: Change from baseline following 56 days of supplement consumption
Perceived sleep quality (VAS)
Time frame: Change from baseline following 56 days of supplement consumption
Subjective Stress (VAS)
Time frame: Change from baseline following 56 days of supplement consumption
Subjective mood (VAS)
Time frame: Change from baseline following 56 days of supplement consumption
Subjective productivity (VAS)
Time frame: Change from baseline following 56 days of supplement consumption
COMPASS global performance measures
Time frame: Change from baseline following 56 days of supplement consumption
Cognitive domain factor score
Time frame: Change from baseline following 56 days of supplement consumption
Cognitive Function under stressful conditions
Time frame: Change from baseline following 56 days of supplement consumption
Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)
Time frame: Change from baseline following 56 days of supplement consumption
Changes in objective stress; as assessed by salivary cortisol levels
Time frame: Change from baseline following 56 days of supplement consumption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
Jason Ellis, PhD principal investigator
Northumbria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Sleep, run by Northumbria University at 2 sites 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 5 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lab-recorded polysomnography- Sleep Quality (time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption). 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 16 Jan 2026.