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

NCT ID: NCT06566157

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2026-09-16

Brief Summary

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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

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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

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Wellbeing Healthy Mental Health

Keywords

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Prebiotics Gut microbiome Microbiome Metabolomics Sequencing Stress Wellbeing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, Placebo, Randomised
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Research nurses, Independent investigators

Study Groups

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Prebiotic

WellBiome® prebiotic complex Inulin 67%, Xylooligosaccharides (XOS) 27%, Magnesium Chloride (MgCl2) 9.8 %

Group Type EXPERIMENTAL

Prebiotic

Intervention Type DIETARY_SUPPLEMENT

WellBiome® prebiotic complex: Inulin 67%, XOS 27%, Magnesium Chloride (MgCl2) 9.8 %

Maltodextrin

Maltodextrin (Corn origin)

Group Type PLACEBO_COMPARATOR

Maltodextrin (Corn)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Prebiotic

WellBiome® prebiotic complex: Inulin 67%, XOS 27%, Magnesium Chloride (MgCl2) 9.8 %

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin (Corn)

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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WellBiome® WellBiome® - Mineral Enriched Prebiotic Fibre Complex Inulin XOS Magnesium Chloride Maltodextrin Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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OptiBiotix Health Plc

UNKNOWN

Sponsor Role collaborator

University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan R Swann, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Southampton, Faculty of Medicine - Human Development and Health

Locations

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NIHR Southampton Clinical Research Facility

Southampton, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Michael L Harvey

Role: CONTACT

Phone: (+44) 023 8120 8226

Email: [email protected]

Jonathan R Swann, Professor

Role: CONTACT

Email: [email protected]

Facility Contacts

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Michael L Harvey, PhD Student

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31525562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29228000 (View on PubMed)

Other Identifiers

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89554

Identifier Type: OTHER

Identifier Source: secondary_id

340693

Identifier Type: -

Identifier Source: org_study_id