Trials / Active Not Recruiting
Active Not RecruitingNCT05239845
Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress
Evaluating the Effects of Prebiotic-based Interventions on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress Following 56 Days Consumption in Healthy Volunteers
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Northumbria University · Academic / Other
- Sex
- All
- Age
- 25 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The aim of the proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting poor sleep quality.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Prebiotic | The bioactive ingredients used in this study include bovine milk fat globule membrane (MFGM), bovine lactoferrin and a prebiotic blend of polydextrose and galactooligosaccharides (PDX/GOS). |
| OTHER | Control | Maltodextrin |
Timeline
- Start date
- 2022-03-03
- Primary completion
- 2024-06-28
- Completion
- 2026-12-01
- First posted
- 2022-02-15
- Last updated
- 2026-01-16
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05239845. Inclusion in this directory is not an endorsement.