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

Launched by UNIVERSITY OF SOUTHAMPTON · Aug 20, 2024

Keywords

ClinConnect Summary

The PROMOTE trial is looking at whether taking a prebiotic supplement for six weeks can help improve the wellbeing of healthy young adults who experience mild to moderate stress. A prebiotic is a type of fiber that helps feed the good bacteria in our gut, and researchers want to see if it can lower morning cortisol levels, which is a hormone related to stress. Participants will continue their normal daily activities while also taking either the prebiotic or a placebo (a sugar pill that has no active ingredients). The study will also measure other aspects of wellbeing to see if there are additional benefits.

To be eligible for this study, participants need to be between 18 and 25 years old, have a healthy to slightly overweight body weight, and score within a certain range on a stress questionnaire. They should be in good general health and able to provide some samples (like stool and blood) during the study. Participants will need to attend four visits at Southampton General Hospital over 10 to 11 weeks. It’s important to note that people with certain health issues, those taking specific medications, or those who consume a lot of alcohol will not be able to participate.

Gender

ALL

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