Phase
Condition
N/ATreatment
Prebiotic
Control
Clinical Study ID
Ages 25-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
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 affectssleep (i.e. disorders of the CNS). An initial screening for sleep disorders will beconducted 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 ofbeing affected for three nights per week, or more, this will be followed up using aclinical 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 probioticproducts/supplements (including specifically oligosaccharides)
Participation in any other intervention research trials
Sleeping at a location other than their usual residence more than two nights perweek during participation
Travel across multiple time zones within the last three months or have plannedtravel 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
Study Design
Connect with a study center
Northumbria Sleep Research, Northumbria University
Newcastle,
United KingdomSite Not Available
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