PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults. (NCT06566157) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults.
United Kingdom70 participantsStarted 2025-01-06
Plain-language 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.
Who can participate
Age range18 Years – 25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Existi…
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)