NCT06566157

PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults.

PROMOTE: The Effect of Prebiotic Supplementation on Salivary Cortisol Awakening Response in Young Adults With Mild-To-Moderate Self-Reported Stress: A Double Blinded Parallel Randomised Controlled-Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The study will investigate whether taking a prebiotic for six weeks helps to reduce morning cortisol levels in healthy young adults with mild to moderate stress compared to a placebo. Individuals should continue with their usual lifestyle during the study. Other factors of wellbeing will also be assessed.

Detailed description

PROMOTE is a double blinded parallel randomised controlled-trial investigating if prebiotic supplementation reduce awakening salivary cortisol response, reported as area under the curve compared to a maltodextrin placebo in healthy young adults with a mild-to-moderate self reported stress score. There will be a focus on biological secondary outcomes to better understand how supplementation may influence the microbiome using metabolomics and sequencing techniques. In addition to other measures of wellbeing captured by questionnaires and activity monitors.

Conditions

• Wellbeing
• Healthy
• Mental Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic	WellBiome® prebiotic complex: Inulin 67%, XOS 27%, Magnesium Chloride (MgCl2) 9.8 %
DIETARY_SUPPLEMENT	Maltodextrin (Corn)	Placebo

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-09-16
• Completion: 2026-09-16
• First posted: 2024-08-22
• Last updated: 2024-12-09

Locations

1 site across 1 country: United Kingdom