Effects of prebiotics on stress and mental health in adults
A Randomised Controlled Trial Exploring the Effects of Prebiotics for Mental Strain and Physiological Markers of Stress in Healthy, Mild-to-Moderately Stressed Adults
This study is testing whether a prebiotic supplement can help adults aged 25 to 40 with mild-to-moderate stress feel better, improve their mental health, and sleep more soundly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 25 Years to 40 Years |
| Sex | All |
| Sponsor | University of Reading Academic / other |
| Locations | 1 site (Reading, Berkshire) |
| Trial ID | NCT06991023 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a prebiotic supplement (Bimuno®) on stress levels, mental health outcomes, and sleep quality in adults aged 25 to 40 who are experiencing mild-to-moderate stress. Utilizing a randomized, placebo-controlled design, 55 participants will be recruited and required to consume the supplement daily while attending in-person sessions for assessments. The study aims to explore how prebiotics can support mental well-being by promoting beneficial gut bacteria and reducing physiological stress responses. Participants will also provide saliva samples to measure cortisol levels throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-40 who are experiencing mild-to-moderate stress.
Not a fit: Patients with recent mental health disorders, significant gastrointestinal issues, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to help reduce stress and improve mental health in affected individuals.
How similar studies have performed: Previous studies have shown promising results regarding the effects of prebiotics on mental health, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 25-40 * Mild-to-moderately stressed as per the stress subscale on the Depression, Anxiety and Stress Scale (DASS-42) Exclusion Criteria: * Antibiotics within 3 months of enrolment * Habitual consumption of pre-, pro-, or synbiotics within 3 months of enrolment * Diagnosis of a mental health disorder within 6 months of enrolment * Use of antidepressant medication within 6 months of enrolment * Smoking (defined as having smoked anytime within a month of enrolment * Following a vegan diet, or dairy or lactose intolerance * Shift workers with unsocial hours * Current or historic gastrointestinal disorder, including IBS and IBD * Current or historic diagnosis of type 1 or 2 diabetes, or any other metabolic disorder * Current or historic diagnosis of any cardiovascular or related disease/illness * Current or historic diagnosis of chronic fatigue or cancer * Current or historic use of weight-loss drugs * Current of historic diagnosis of any disorder affecting cortisol levels, including Cushing's
Where this trial is running
Reading, Berkshire
- Nutrition, Cognition & Health Lab, School of Psychology and Clinical Language Sciences, University of Reading — Reading, Berkshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Daniel Lamport, PhD — University of Reading
- Study coordinator: Jessica R Eastwood, PhD
- Email: jessica.eastwood@reading.ac.uk
- Phone: 0118 378 5615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.