NCT05239845Active, not recruitingNot Applicable
Evaluating the Effects of Prebiotic-based Interventions on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress Following 56 Days Consumption in Healthy Volunteers
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Northumbria University
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Lab-recorded polysomnography- Sleep Quality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Prebiotic (Dietary Supplement)
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.
Intervention: Prebiotic (Dietary Supplement)
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.
Intervention: Prebiotic (Dietary Supplement)
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.
Intervention: Control (Other)
Outcomes
Primary Outcomes
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
- Lab-recorded polysomnography- Time spent in stages of rapid eye movement (REM) and non-REM sleep(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
- Lab-recorded polysomnography- Sleep onset latency(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
- Lab-recorded polysomnography- Total sleep time(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
- Lab-recorded polysomnography- Number of awakenings(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(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
- Lab-recorded polysomnography- REM Rebound(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
- Lab-recorded polysomnography- Sleep microstructure(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
- Actigraphy - Sleep onset latency(Change from baseline following 56 days of supplement consumption)
- Actigraphy - Total sleep time(Change from baseline following 56 days of supplement consumption)
- Actigraphy - Number of awakenings(Change from baseline following 56 days of supplement consumption)
- Actigraphy - Wake after sleep onset (WASO)(Change from baseline following 56 days of supplement consumption)
- Actigraphy - Sleep efficiency(Change from baseline following 56 days of supplement consumption)
- Blood Pressure and Heart Rate (BP/HR)(Change from baseline following 56 days of supplement consumption)
- Waist-to-Hip Ratio (WHR)(Change from baseline following 56 days of supplement consumption)
- Work Productivity and Activity Impairment questionnaire (WPAI)(Change from baseline following 56 days of supplement consumption)
- Gastrointestinal symptoms questionnaire(Change from baseline following 56 days of supplement consumption)
- Sleep Diary -Sleep Latency(Change from baseline following 56 days of supplement consumption)
- Sleep Diary - Wake After Sleep Onset (WASO)(Change from baseline following 56 days of supplement consumption)
- Body Mass Index (BMI)(Change from baseline following 56 days of supplement consumption)
- Perceived Stress Scale (PSS(Change from baseline following 56 days of supplement consumption)
- Sleep Diary -Number of Awakenings(Change from baseline following 56 days of supplement consumption)
- Dietary assessment- Intake24(Change from baseline following 56 days of supplement consumption)
- Subjective Stress (VAS)(Change from baseline following 56 days of supplement consumption)
- Subjective productivity (VAS)(Change from baseline following 56 days of supplement consumption)
- Cognitive domain factor score(Change from baseline following 56 days of supplement consumption)
- Cognitive Function under stressful conditions(Change from baseline following 56 days of supplement consumption)
- Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)(Change from baseline following 56 days of supplement consumption)
- Pittsburgh Sleep Quality Index (PSQI)(Change from baseline following 56 days of supplement consumption)
- Profile of Mood States (POMS)(Change from baseline following 56 days of supplement consumption)
- State-Trait Anxiety Inventory (STAI)(Change from baseline following 56 days of supplement consumption)
- Depression, Anxiety and Stress Scale - 21 Items (DASS-21)(Change from baseline following 56 days of supplement consumption)
- 12-Item Short Form Survey (SF-12)(Change from baseline following 56 days of supplement consumption)
- Sleep Diary -Total Sleep Time(Change from baseline following 56 days of supplement consumption)
- Sleep Diary -Time in bed(Change from baseline following 56 days of supplement consumption)
- Sleep Diary - Sleep Efficiency(Change from baseline following 56 days of supplement consumption)
- Sleep Diary - Sleep Quality(Change from baseline following 56 days of supplement consumption)
- Perceived sleep quality (VAS)(Change from baseline following 56 days of supplement consumption)
- Subjective mood (VAS)(Change from baseline following 56 days of supplement consumption)
- COMPASS global performance measures(Change from baseline following 56 days of supplement consumption)
- Changes in objective stress; as assessed by salivary cortisol levels(Change from baseline following 56 days of supplement consumption)
- Changes in objective stress; as assessed by salivary alpha-amylase levels(Change from baseline following 56 days of supplement consumption)
- Changes in objective stress; as assessed by galvanic skin response (GSR)(Change from baseline following 56 days of supplement consumption)
- Changes in objective stress; as assessed by heart rate (HR)(Change from baseline following 56 days of supplement consumption)
- Gut microbiome assessments (gut bacterial profile)(Change from baseline following 56 days of supplement consumption)
- Immunological marker Assessment -Blood(Change from baseline following 56 days of supplement consumption)
Investigators
Study Sites (2)
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