Clinical trial NCT06566157: PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wellbeing
Healthy
Mental Health
Keywords: Prebiotics
Gut microbiome
Microbiome
Metabolomics
Sequencing
Stress
Wellbeing
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: OptiBiotix Health Plc
First posted: 2024-08-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, Placebo, Randomised
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Aged 18-25 at time of recruitment
* Body Mass Index (18.5 - 29.9 kg) : Healthy - Overweight
* Stress score of 15≤ - ≥25 (DASS)
* Willing and with capacity to give informed consent to participate at time of recruitment
* Speak and comprehend English to a good standard
* In good general health
* Willing to provide stool, urine and blood (8mL) sample during intervention
* Willing to attend 4 visits to Southampton General Hospital Clinical Research Facility over 10-11 weeks

Exclusion Criteria:

* Consuming ≥ 14 units of alcohol/week (6 x 175 mL of wine, 6 pints of 4% beer)
* Learning or behavioural difficulties (assessed on individual basis)
* Planning a pregnancy in the next 6 months, pregnant, lactating or had a recent birth ≥6 months
* Currently smoking or using e-cigarette, vape
* Vulnerable adults (with self reported sever or very severe stress score (DASS)
* Unwilling to suspend existing probiotic / prebiotic supplementation (with additional 4 weeks washout) before starting study.

Medical exclusions:

* Actively involved in therapy or psychiatric intervention of a diagnosed mental health condition
* Prescribed psychotropic medication (Antidepressants, Monoamine Oxidase Inhibitors (MAOI's), Antipsychotics, sleeping pills, mood stabilisers etc)
* Allergic to milk, soy, corn, penicillin or fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS)
* Currently prescribed laxatives, enemas, anti-coagulants or painkillers
* Existing medical condition: cancer, hepatobiliary surgery, diabetes or diagnosed gastrointestinal diseases (irritable bowel disease, ulcerative colitis)
* Involved in a recent pharmacology/psychological intervention, last 6 months
* Recent antibiotic prescription, last 6 months

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)
Secondary outcomes:
measure: Good Sleeper Scale -15 items (GSS -15) self-reported sleep.
timeFrame: 3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley
measure: Depression Anxiety and Stress Scales 42-items (DASS-42) questionnaire. Wellbeing and subjective mental health assessment.
timeFrame: 3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley
measure: Faceal microbial sequencing and interventional group microbiota compositional change
timeFrame: Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).
measure: Short Food Frequency Questionnaire (SFFQ): Diet quality score
timeFrame: 3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley
measure: Activity monitoring using activewear devices
timeFrame: Continuous / 3 nights per 14 days (2 weeknights, 1 weekend night) depending on participants preference.
measure: Urine Metabolomics (Untargeted)
timeFrame: Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).
measure: Faeces Metabolomics (Untargeted)
timeFrame: Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).
measure: Plasma Metabolomics (Untargeted)
timeFrame: 3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley
measure: Anthropometrics - Body composition
timeFrame: 3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley
measure: Adverse effects monitoring
timeFrame: Continuous monitoring from start to end of study for all participants
Other outcomes:
measure: Urine Metabolomics (Targeted)
timeFrame: Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).
measure: Faeces Metabolomics (Targeted)
timeFrame: Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).
measure: Plasma Metabolomics (Targeted)
timeFrame: 3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley
Locations:
city: Southampton
country: United Kingdom
facility: NIHR Southampton Clinical Research Facility
state: Hampshire
Study officials:
affiliation: University of Southampton, Faculty of Medicine - Human Development and Health
name: Jonathan R Swann, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caspani G, Swann J. Small talk: microbial metabolites involved in the signaling from microbiota to brain. Curr Opin Pharmacol. 2019 Oct;48:99-106. doi: 10.1016/j.coph.2019.08.001. Epub 2019 Sep 14.
citation: Costabile A, Buttarazzi I, Kolida S, Quercia S, Baldini J, Swann JR, Brigidi P, Gibson GR. An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. PLoS One. 2017 Dec 11;12(12):e0187964. doi: 10.1371/journal.pone.0187964. eCollection 2017.