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

NCT07369869 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Stress
  • Sleep
  • Cognition
  • Nutrition
  • Microbiome

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

Sponsors & Collaborators

  • Northumbria University

    lead OTHER

Principal Investigators

  • Professor Jason Ellis, PhD · Northumbria University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369869 on ClinicalTrials.gov