Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorNorthumbria University
About this trial
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants must self-assess themselves as being in good health.
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).
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Proprietary 'active' composition 1
Dietary supplementA proprietary orally administered dietary supplement consisting of standardized ingredients.
Proprietary 'active' composition 2
Dietary supplementA proprietary orally administered dietary supplement consisting of standardized ingredients.
Inactive control supplement
Dietary supplementFlavored vehicle
Treatment groups
68 Participants
are divided into 3 treatment groupsGroup A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed.
Time frame
Change from Baseline to end of supplementation period at 28 daysSecondary outcomes
1
Actigraphy - Sleep onset latency
recorded minutes taken from intention to sleep to sleep initiation
Time frame
Change from baseline following 28 days of supplement consumption2
Actigraphy - Sleep efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Time frame
Change from baseline following 28 days of supplement consumption3
Actigraphy - Number of awakenings
recorded number of awakenings during entire sleep period
Time frame
Change from baseline following 28 days of supplement consumption4
Actigraphy - Wake after sleep onset (WASO)
recorded minutes awake during the entire sleep period following sleep onset
Time frame
Change from baseline following 28 days of supplement consumptionSponsors and contacts
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Source ClinicalTrials.gov
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