An interventional study of Prebiotic and Control in Sleep, sponsored by Northumbria University. Active, not recruiting at 2 sites in United Kingdom. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Northumbria University · Not applicable, Interventional, and Other
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.
Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Prebiotic
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.
Dietary Supplement: Prebiotic
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.
Dietary Supplement: Prebiotic
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.
Other: Control
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).
Maltodextrin
Lab-recorded polysomnography- Sleep Quality
percentage of time in staged sleep from total sleep recorded time
Time frame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Lab-recorded polysomnography- Sleep onset latency
minutes taken from intention to sleep to first epoch of any stage of sleep
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
minutes of staged sleep over entire sleep duration period
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
number of \<15 second bouts of Wake surrounded, at both ends, by any sleep stage
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
cumulative minutes of scored Wake during entire sleep duration following sleep initiation
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
percentage of time spent in REM, N1, N2, N3
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
length, frequency and depth of 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- Sleep microstructure
including k-complexes - \>.0.5 secs. negative then positive wave and fast/slow sleep spindles - \>.0.5 secs. sinusoidal waves 11-16Hz
Time frame: 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
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Total sleep time
recorded minutes asleep over entire sleep period
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Number of awakenings
recorded number of awakenings during entire sleep period
Time frame: 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
Time frame: 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)
Time frame: Change from baseline following 56 days of supplement consumption
Blood Pressure and Heart Rate (BP/HR)
Measured using a fully automatic oscillometric device
Time frame: Change from baseline following 56 days of supplement consumption
Body Mass Index (BMI)
calculated using standard formula: weight (kg) / \[height (m)\]2
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary -Number of Awakenings
number of perceived awakenings over the sleep period
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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')
Time frame: 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')
Time frame: 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')
Time frame: 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')
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: Change from baseline following 56 days of supplement consumption
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Northumbria University