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Active, Not Recruiting

NCT Number: NCT05239845

Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sleep

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria Sleep Research, Northumbria University, Newcastle, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Prebiotic

Dietary 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).

Control

Other

Maltodextrin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    minutes taken from intention to sleep to first epoch of any stage of sleep

  2. 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

    minutes of staged sleep over entire sleep duration period

  3. 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

    number of <15 second bouts of Wake surrounded, at both ends, by any sleep stage

  4. 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

    cumulative minutes of scored Wake during entire sleep duration following sleep initiation

  5. 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

    percentage of time spent in REM, N1, N2, N3

  6. 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

    length, frequency and depth of REM sleep

  7. 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

    including k-complexes - >.0.5 secs. negative then positive wave and fast/slow sleep spindles - >.0.5 secs. sinusoidal waves 11-16Hz

  8. Actigraphy - Sleep onset latency

    Time frame: Change from baseline following 56 days of supplement consumption

    recorded minutes taken from intention to sleep to sleep initiation

  9. Actigraphy - Total sleep time

    Time frame: Change from baseline following 56 days of supplement consumption

    recorded minutes asleep over entire sleep period

  10. Actigraphy - Number of awakenings

    Time frame: Change from baseline following 56 days of supplement consumption

    recorded number of awakenings during entire sleep period

  11. Actigraphy - Wake after sleep onset (WASO)

    Time frame: Change from baseline following 56 days of supplement consumption

    recorded minutes awake during the entire sleep period following sleep onset

  12. Actigraphy - Sleep efficiency

    Time frame: Change from baseline following 56 days of supplement consumption

    ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)

  13. Blood Pressure and Heart Rate (BP/HR)

    Time frame: Change from baseline following 56 days of supplement consumption

    Measured using a fully automatic oscillometric device

  14. Body Mass Index (BMI)

    Time frame: Change from baseline following 56 days of supplement consumption

    calculated using standard formula: weight (kg) / [height (m)]2

  15. Waist-to-Hip Ratio (WHR)

    Time frame: Change from baseline following 56 days of supplement consumption

    WHR will be calculated by dividing waist circumference by hip circumference.

  16. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline following 56 days of supplement consumption

    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.

  17. Profile of Mood States (POMS)

    Time frame: Change from baseline following 56 days of supplement consumption

    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)

  18. Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

    Time frame: Change from baseline following 56 days of supplement consumption

    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.

  19. State-Trait Anxiety Inventory (STAI)

    Time frame: Change from baseline following 56 days of supplement consumption

    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.

  20. Work Productivity and Activity Impairment questionnaire (WPAI)

    Time frame: Change from baseline following 56 days of supplement consumption

    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.

  21. 12-Item Short Form Survey (SF-12)

    Time frame: Change from baseline following 56 days of supplement consumption

    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.

  22. Perceived Stress Scale (PSS

    Time frame: Change from baseline following 56 days of supplement consumption

    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

  23. Gastrointestinal symptoms questionnaire

    Time frame: Change from baseline following 56 days of supplement consumption

    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

  24. Sleep Diary -Total Sleep Time

    Time frame: Change from baseline following 56 days of supplement consumption

    how long, in minutes, the individual reports being asleep during the night between initiation and termination of sleep, accounting for nocturnal wake periods

  25. Sleep Diary -Time in bed

    Time frame: Change from baseline following 56 days of supplement consumption

    how long, in minutes, the individual reports being in bed intending to sleep

  26. Sleep Diary -Sleep Latency

    Time frame: Change from baseline following 56 days of supplement consumption

    how long, in minutes, the individual felt it took them to fall asleep after intending to sleep

  27. Sleep Diary -Number of Awakenings

    Time frame: Change from baseline following 56 days of supplement consumption

    number of perceived awakenings over the sleep period

  28. Sleep Diary - Wake After Sleep Onset (WASO)

    Time frame: Change from baseline following 56 days of supplement consumption

    how long, in minutes, the individual reports being awake during the night after sleep initiation

  29. Sleep Diary - Sleep Efficiency

    Time frame: Change from baseline following 56 days of supplement consumption

    Total Sleep Time divided by Time in Bed x 100, expressed as a percentage

  30. Sleep Diary - Sleep Quality

    Time frame: Change from baseline following 56 days of supplement consumption

    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.

  31. Dietary assessment- Intake24

    Time frame: Change from baseline following 56 days of supplement consumption

    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.

  32. Perceived sleep quality (VAS)

    Time frame: Change from baseline following 56 days of supplement consumption

    Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')

  33. Subjective Stress (VAS)

    Time frame: Change from baseline following 56 days of supplement consumption

    Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')

  34. Subjective mood (VAS)

    Time frame: Change from baseline following 56 days of supplement consumption

    Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')

  35. Subjective productivity (VAS)

    Time frame: Change from baseline following 56 days of supplement consumption

    Assessed weekly via numerical rating scales. This will generate individual scores of 0-4 (0= 'Extremely poor' to 4= 'Extremely good')

  36. COMPASS global performance measures

    Time frame: Change from baseline following 56 days of supplement consumption

    Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)

  37. Cognitive domain factor score

    Time frame: Change from baseline following 56 days of supplement consumption

    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)

  38. Cognitive Function under stressful conditions

    Time frame: Change from baseline following 56 days of supplement consumption

    Cognitive performance (multi tasking using Serial Subtractions (3s, 7s, 17s) and tracking simultaneously) during acute stress as a consequence of theOBSERVED MULTITASKING STRESSOR (OMS)

  39. Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)

    Time frame: Change from baseline following 56 days of supplement consumption

    Subjective stress will be measured via the state, trait anxiety inventory before and after each completion of the observed multitasking stressor (OMS)

  40. Changes in objective stress; as assessed by salivary cortisol levels

    Time frame: Change from baseline following 56 days of supplement consumption

    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

  41. Changes in objective stress; as assessed by salivary alpha-amylase levels

    Time frame: Change from baseline following 56 days of supplement consumption

    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

  42. Changes in objective stress; as assessed by galvanic skin response (GSR)

    Time frame: Change from baseline following 56 days of supplement consumption

    Galvanic skin response (GSR) will be recorded throughout the observed multitasking stressor (OMS)

  43. Changes in objective stress; as assessed by heart rate (HR)

    Time frame: Change from baseline following 56 days of supplement consumption

    Heart rate (HR) will be recorded throughout the observed multitasking stressor (OMS)

  44. Gut microbiome assessments (gut bacterial profile)

    Time frame: Change from baseline following 56 days of supplement consumption

    Assessed via analysis of self collected stool samples at baseline, during active supplementation and after 56 days of supplementation.

  45. Immunological marker Assessment -Blood

    Time frame: Change from baseline following 56 days of supplement consumption

    Immune function (identification of blood biomarkers of immune function in samples collected at baseline and chronic lab visits)

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Reckitt Benckiser Group PLC

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Jan 16, 2026

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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