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Thymogen

Glu-Trp, EW dipeptide, Oglufanide, L-Glutamyl-L-tryptophan

Quick Stats
Studies 94
Trials 51
Not Yet Recruiting NA INTERVENTIONAL NCT06566157

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Salivary Cortisol Awakening Response - Biological salivary cortisol (µg/dL)
TimeFrame: 6 collections across two working mornings per timepoint. (2 'baseline' - week 0 before supplementation; 2 'endpoint' - week 6 of supplementation ; 2 'follow-up' - within 3rd week (week 9) of supplement end)
Description: Salivary Cortisol Awakening Response (µg/dL) Measured on awakening and hereafter at 0, 15 , 30, 45 minutes Quantified by ELISA and presented as area under the curve, for each timepoint. Example outcome: 'Awakening salivary cortisol response was significantly lower in the prebiotic group compared to the placebo mean difference: -2.27( 95CI-3.68, -0.87) group after 6 weeks of supplementation.' \[result sourced from clinicaltrials.gov NCT0521254\]

Trial Information

NCT ID

NCT06566157

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

University of Southampton

Last Updated

December 15, 2025