Status:
NOT_YET_RECRUITING
PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults.
Lead Sponsor:
University of Southampton
Collaborating Sponsors:
OptiBiotix Health Plc
Conditions:
Wellbeing
Healthy
Eligibility:
All Genders
18-25 years
Phase:
NA
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 shou...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 16 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06566157
Start Date
January 6 2025
End Date
September 16 2026
Last Update
December 9 2024
Active Locations (1)
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1
NIHR Southampton Clinical Research Facility
Southampton, Hampshire, United Kingdom, SO16 6YD