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

Starting soon · Not applicable

Conditions studied: Stress, Sleep, Cognition, Nutrition, Microbiome

In brief

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.

Key facts

Study ID

NCT07369869

Run by

Northumbria University

People needed

68

Starts

2026-05-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-03

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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
• Currently, or within the previous 8 weeks, consuming any nutritional supplements.
• Participation in any other intervention research trials
• Sleeping at a location other than their usual residence more than two nights per week during participation
• Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study
• Current or recent mood disturbances or Axis I disorders (descriptions will be given)
• 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

Where it is running

• Northumbria University- Northumbria Sleep center and NUTRAN — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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