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

NCT06566157 | Not Yet Recruiting

• 2 other identifiers: 34069389554
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Wellbeing; Healthy; Mental Health

Keywords

Prebiotics; Gut microbiome; Microbiome; Metabolomics; Sequencing; Stress; Wellbeing

Outcome Measures

Primary Outcomes (1)

• Salivary Cortisol Awakening Response - Biological salivary cortisol (µg/dL)

  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.' \[result sourced from clinicaltrials.gov NCT0521254\]

  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 (10)

• Good Sleeper Scale -15 items (GSS -15) self-reported sleep.

  3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley

• Depression Anxiety and Stress Scales 42-items (DASS-42) questionnaire. Wellbeing and subjective mental health assessment.

  3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley

• Faceal microbial sequencing and interventional group microbiota compositional change

  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).

• Short Food Frequency Questionnaire (SFFQ): Diet quality score

  3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley

• Activity monitoring using activewear devices

  Continuous / 3 nights per 14 days (2 weeknights, 1 weekend night) depending on participants preference.

Other Outcomes (3)

• Urine Metabolomics (Targeted)

  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).

• Faeces Metabolomics (Targeted)

  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).

• Plasma Metabolomics (Targeted)

  3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley

Study Arms (2)

Prebiotic

EXPERIMENTAL

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

Dietary Supplement: Prebiotic

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin (Corn origin)

Dietary Supplement: Maltodextrin (Corn)

Interventions

Prebiotic DIETARY_SUPPLEMENT

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

Also known as: WellBiome®, WellBiome® - Mineral Enriched Prebiotic Fibre Complex, Inulin, XOS, Magnesium Chloride

Prebiotic

Maltodextrin (Corn) DIETARY_SUPPLEMENT

Placebo

Also known as: Maltodextrin Placebo

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Southampton: lead
• OptiBiotix Health Plc: collaborator

Study Sites (1)

NIHR Southampton Clinical Research Facility

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31525562 BACKGROUND

• 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.

  PMID: 29228000 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Prebiotics; Inulin; Magnesium Chloride; maltodextrin

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Fructans; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Magnesium Compounds

Study Officials

• Jonathan R Swann, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael L Harvey

CONTACT

(+44) 023 8120 8226; m.l.harvey@soton.ac.uk

Jonathan R Swann, Professor

CONTACT

j.swann@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research nurses, Independent investigators
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, Placebo, Randomised

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 22, 2024
• Study Start: January 6, 2025
• Primary Completion: September 16, 2025
• Study Completion (Estimated): September 16, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)