Clinical trial NCT06991023: Prebiotic Effects on Anxiety, Cortisol, and Emotional Processing in Mild-to-Moderately Stressed Adults
Official title: A Randomised Controlled Trial Exploring the Effects of Prebiotics for Mental Strain and Physiological Markers of Stress in Healthy, Mild-to-Moderately Stressed Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild-to-Moderate Stress
Keywords: Randomised Controlled Trial
Stress
Cortisol
Prebiotic
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Clasado Research Services Ltd
First posted: 2025-05-25
Enrollment: 55
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study employs a parallel groups, randomised, placebo-controlled design in 55 (allowing for 10% attrition) adults aged 25 - 40 experiencing mild-to-moderate stress. Information sheet, consent form, screening and collection of demographic data will be conducted via Redcap at the start of the study. Each participant will then attend 3 in-person sessions at the UoR Psychology department - 1 practice session, and 2 study visits 6 weeks apart. Between the study visits, participants will be required to consume a prebiotic supplement (Bimuno®) once a day at home, and collect saliva samples on 4 occasions.

Screening (all conducted via Redcap) All participants will read through the participant information sheet and sign the consent form before completing a health and lifestyle screening questionnaire to collect demographic data and ensure they meet the eligibility criteria. If eligible, subjects will then be invited to attend an in-person practice visit.

Practice visit The practice visit will be conducted in the Nutrition, Cognition and Health lab in the Psychology department, at any time of day (within working hours) to suit the participant. During this visit, the researcher will double-check participant eligibility and talk the subject through the full trial protocol. Participants will then complete the mood questionnaires and one practice round of the cognitive task (detailed in the study visit section below). This allows participants to see the type of questions they will be asked and ensure they're comfortable answering them, as well as ensure competency on the task before collecting data in the study visits. Finally, participants will be provided with two cycles worth of saliva sample kits and a demonstration on how collect their saliva samples.

Study visit(s) Subjects will consume a standardised breakfast of one slice of white toast and butter with water at home prior to arrival (or, if the participant does not routinely eat breakfast, they may arrive for the visits fasted). Study visits will be conducted in the Nutrition, Cognition and Health lab in the Psychology department, and participants will have the option to arrive anytime between 8am and 11am. This allows participants to complete their study visits before starting their work day if necessary, but also ensures that all sessions are complete before lunch removing the need to provide standardised lunch for participants. Start time of sessions will be kept consistent across visits within participants, as will the choice to have breakfast or not. During the study visits, participants will complete the following mood and sleep questionnaires in a fixed order using Redcap.

Following the questionnaires, participants will complete two emotional cognition tasks in order to explore how the prebiotic supplement might affect emotional processing. All measures will be administered via Inquisit.

At the end of the first study visit, subjects will be provided with their intervention sachets and two more cycles-worth of saliva kits to be used at the end of the study. At the end of the second visit, participants will be given the debrief sheet and emailed a payment form to complete. Both the prebiotic and the matched placebo are supplied by Clasado Research Services Ltd, Reading UK.

Eligibility 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

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline
measure: Perceived Stress Scale (PSS)
timeFrame: Post-intervention (6 weeks)
Secondary outcomes:
measure: Positive and Negative Affect Schedule - expanded (PANAS-x)
timeFrame: Baseline
measure: Positive and Negative Affect Schedule - expanded (PANAS-x)
timeFrame: 6 weeks
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Post-intervention (6 weeks)
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Post-intervention (6 weeks)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Post-intervention (6 weeks)
measure: Salivary Cortisol
timeFrame: 1 day before baseline
measure: Salivary Cortisol
timeFrame: Baseline
measure: Salivary Cortisol
timeFrame: 1 day before post-intervention measures (6 weeks)
measure: Salivary Cortisol
timeFrame: Post-intervention (6 weeks)
measure: Epic-Norfolk Food Frequency Questionnaire
timeFrame: Baseline
measure: FibreScreen
timeFrame: Baseline
measure: FibreScreen
timeFrame: Post-intervention (6 weeks)
measure: Emotion dot probe task
timeFrame: Baseline
measure: Emotion dot probe task
timeFrame: Post-intervention (6 weeks)
measure: Emotion Go/No-Go task
timeFrame: Baseline
measure: Emotion Go/No-Go task
timeFrame: Post-intervention (6 weeks)
measure: Gastrointestinal Symptoms Rating Scale (GSRS)
timeFrame: Post-intervention (6 weeks)
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Nutrition, Cognition & Health Lab, School of Psychology and Clinical Language Sciences, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Daniel Lamport, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Reading
name: Piril Hepsomali
role: STUDY_DIRECTOR
affiliation: University of Reading
name: Claire Williams
role: STUDY_DIRECTOR
References: