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

Phase 4

Not yet recruiting

• Conditions: Wellbeing; Healthy

• Registration Number: NCT06566157
• Lead Sponsor: University of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Inclusion Criteria:<br><br> - Aged 18-25 at time of recruitment<br><br> - Body Mass Index (18.5 - 29.9 kg) : Healthy - Overweight<br><br> - Stress score of 15= - =25 (DASS)<br><br> - Willing and with capacity to give informed consent to participate at time of<br> recruitment<br><br> - Speak and comprehend English to a good standard<br><br> - In good general health<br><br> - Willing to provide stool, urine and blood (8mL) sample during intervention<br><br> - Willing to attend 4 visits to Southampton General Hospital Clinical Research<br> Facility over 10-11 weeks<br><br>Exclusion Criteria:<br><br> - Consuming = 14 units of alcohol/week (6 x 175 mL of wine, 6 pints of 4% beer)<br><br> - Learning or behavioural difficulties (assessed on individual basis)<br><br> - Planning a pregnancy in the next 6 months, pregnant, lactating or had a recent birth<br> =6 months<br><br> - Currently smoking or using e-cigarette, vape<br><br> - Vulnerable adults (with self reported sever or very severe stress score (DASS)<br><br> - Unwilling to suspend existing probiotic / prebiotic supplementation (with additional<br> 4 weeks washout) before starting study.<br><br>Medical exclusions:<br><br> - Actively involved in therapy or psychiatric intervention of a diagnosed mental<br> health condition<br><br> - Prescribed psychotropic medication (Antidepressants, Monoamine Oxidase Inhibitors<br> (MAOI's), Antipsychotics, sleeping pills, mood stabilisers etc)<br><br> - Allergic to milk, soy, corn, penicillin or fermentable oligosaccharides,<br> disaccharides, monosaccharides, and polyols (FODMAPS)<br><br> - Currently prescribed laxatives, enemas, anti-coagulants or painkillers<br><br> - Existing medical condition: cancer, hepatobiliary surgery, diabetes or diagnosed<br> gastrointestinal diseases (irritable bowel disease, ulcerative colitis)<br><br> - Involved in a recent pharmacology/psychological intervention, last 6 months<br><br> - Recent antibiotic prescription, last 6 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary Cortisol Awakening Response - Biological salivary cortisol (µg/dL)

Secondary Outcome Measures

Name	Time	Method
Good Sleeper Scale -15 items (GSS -15) self-reported sleep.;Depression Anxiety and Stress Scales 42-items (DASS-42) questionnaire. Wellbeing and subjective mental health assessment.;Faceal microbial sequencing and interventional group microbiota compositional change;Short Food Frequency Questionnaire (SFFQ): Diet quality score;Activity monitoring using activewear devices;Urine Metabolomics (Untargeted);Faeces Metabolomics (Untargeted);Plasma Metabolomics (Untargeted);Anthropometrics - Body composition;Adverse effects monitoring