Prebiotic Effects on Anxiety, Cortisol, and Emotional Processing in Mild-to-Moderately Stressed A… (NCT06991023) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prebiotic Effects on Anxiety, Cortisol, and Emotional Processing in Mild-to-Moderately Stressed Adults
United Kingdom55 participantsStarted 2025-03-31
Plain-language summary
The levels of stress that we experience as a population are continuing to rise due to financial, social and work pressures, particularly in mid-life where additional factors such as family and career often compound these issues. When we experience high levels of stress for prolonged periods, this often has detrimental effects on our mental and physical wellbeing, leading to chronic illness and mental health disorders.
Prebiotics are non-digestible fibres found in food and supplements which promote the growth of beneficial bacteria that produce short-chain fatty acids (SCFAs). Research shows that prebiotics may be used as a lifestyle intervention to support individuals experiencing stress and help reduce physiological and psychological feelings of stress.
As such, this study will build on previous research and explore whether a prebiotic supplement (Bimuno®) has a beneficial effect on stress, mental health outcomes, and sleep in mild-to-moderately stressed adults. To address these questions, participants will take the prebiotic or a placebo for 6 weeks, and visit the University of Reading to complete some questionnaires and cognitive tests at the start and end of the trial. The investigators will also ask participants to collect saliva samples to see if the prebiotics influence cortisol levels, which are linked to stress.
Who can participate
Age range
25 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 25-40
* Meeting at least mildly stressed as per the stress subscale on the Depression, Anxiety and Stress Scale (DASS-42) (score of 15 or more)
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.