Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07369869 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Oct 2026 to Dec 2026
    • Start date: Apr 2026 to May 2026
    • Collaborators shortened, about 3 words
    v3
  2. Interventions: Inactive control supplement (Dietary Supplement), prebiotic/fiber 'active' composition 1 (Dietary Supplement), prebiotic/fiber 'active'… to Inactive control supplement (Dietary Supplement), Proprietary 'active' composition 1 (Dietary Supplement), Proprietary 'active' composition…
    • Study description shortened, about 28 words
    • Eligibility criteria shortened, about 5 words
    • Study title shortened, about 2 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07369869
Lead Sponsor Northumbria University
Conditions
(from sponsor)		 Stress, Sleep, Cognition, Nutrition, Microbiome
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov