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.

NCT07369869 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	Northumbria University
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	68
Start date	2026-05
Completion	2026-12

Conditions

• Stress
• Sleep
• Cognition
• Nutrition
• Microbiome

Interventions

• Proprietary 'active' composition 1
• Proprietary 'active' composition 2
• Inactive control supplement

Primary outcomes

• Sleep Efficiency (SE) — Change from Baseline to end of supplementation period at 28 days
  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.

Countries

United Kingdom