Clinical trial NCT05239845: Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Keywords: Gut Microbiome
Stress
Immune Function
Cognition
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Reckitt Benckiser Group PLC
First posted: 2022-02-15
Enrollment: 68
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 poor sleep quality.


Eligibility criteria: 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

Primary outcomes:
measure: Lab-recorded polysomnography- Sleep Quality
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
Secondary outcomes:
measure: Lab-recorded polysomnography- Sleep onset latency
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
measure: Lab-recorded polysomnography- Total sleep time
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
measure: Lab-recorded polysomnography- Number of awakenings
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
measure: Lab-recorded polysomnography- Wake after sleep onset
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
measure: Lab-recorded polysomnography- Time spent in stages of rapid eye movement (REM) and non-REM sleep
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
measure: Lab-recorded polysomnography- REM Rebound
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
measure: Lab-recorded polysomnography- Sleep microstructure
timeFrame: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption
measure: Actigraphy - Sleep onset latency
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Actigraphy - Total sleep time
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Actigraphy - Number of awakenings
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Actigraphy - Wake after sleep onset (WASO)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Actigraphy - Sleep efficiency
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Blood Pressure and Heart Rate (BP/HR)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Body Mass Index (BMI)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Waist-to-Hip Ratio (WHR)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Profile of Mood States (POMS)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Work Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: 12-Item Short Form Survey (SF-12)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Perceived Stress Scale (PSS
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Gastrointestinal symptoms questionnaire
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Sleep Diary -Total Sleep Time
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Sleep Diary -Time in bed
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Sleep Diary -Sleep Latency
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Sleep Diary -Number of Awakenings
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Sleep Diary - Wake After Sleep Onset (WASO)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Sleep Diary - Sleep Efficiency
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Sleep Diary - Sleep Quality
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Dietary assessment- Intake24
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Perceived sleep quality (VAS)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Subjective Stress (VAS)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Subjective mood (VAS)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Subjective productivity (VAS)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: COMPASS global performance measures
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Cognitive domain factor score
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Cognitive Function under stressful conditions
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Changes in objective stress; as assessed by salivary cortisol levels
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Changes in objective stress; as assessed by salivary alpha-amylase levels
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Changes in objective stress; as assessed by galvanic skin response (GSR)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Changes in objective stress; as assessed by heart rate (HR)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Gut microbiome assessments (gut bacterial profile)
timeFrame: Change from baseline following 56 days of supplement consumption
measure: Immunological marker Assessment -Blood
timeFrame: Change from baseline following 56 days of supplement consumption
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Northumbria Sleep Research, Northumbria University
Study officials:
References: