Status:
ACTIVE_NOT_RECRUITING
Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress
Lead Sponsor:
Northumbria University
Collaborating Sponsors:
Reckitt Benckiser Group PLC
Conditions:
Sleep
Eligibility:
All Genders
25-60 years
Phase:
NA
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 form...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05239845
Start Date
March 3 2022
End Date
December 1 2024
Last Update
October 24 2024
Active Locations (1)
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1
Northumbria Sleep Research, Northumbria University
Newcastle, United Kingdom