Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and… (NCT05239845) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress
United Kingdom68 participantsStarted 2022-03-03
Plain-language 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.
Who can participate
Age range25 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Lab-recorded polysomnography- Sleep Quality
Timeframe: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption