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Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.
Sponsor: Northumbria University
Summary
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.
Official title: Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress Following 28 Days Consumption in Adults Reporting Sub-clinical Sleep Deficits: A Randomised, Double-blind, Placebo-controlled, Three-arm Parallel Groups Trial.
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2026-05
Completion Date
2026-12
Last Updated
2026-03-03
Healthy Volunteers
Yes
Conditions
Interventions
Proprietary 'active' composition 1
A proprietary orally administered dietary supplement consisting of standardized ingredients.
Proprietary 'active' composition 2
A proprietary orally administered dietary supplement consisting of standardized ingredients.
Inactive control supplement
Flavored vehicle
Locations (1)
Northumbria University- Northumbria Sleep center and NUTRAN
Newcastle upon Tyne, United Kingdom