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NOT YET RECRUITING
NCT07369869
NA

Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.

Sponsor: Northumbria University

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Proprietary 'active' composition 1

A proprietary orally administered dietary supplement consisting of standardized ingredients.

DIETARY_SUPPLEMENT

Proprietary 'active' composition 2

A proprietary orally administered dietary supplement consisting of standardized ingredients.

DIETARY_SUPPLEMENT

Inactive control supplement

Flavored vehicle

Locations (1)

Northumbria University- Northumbria Sleep center and NUTRAN

Newcastle upon Tyne, United Kingdom