Status:
ACTIVE_NOT_RECRUITING
Prebiotic Effects on Anxiety, Cortisol, and Emotional Processing in Mild-to-Moderately Stressed Adults
Lead Sponsor:
University of Reading
Collaborating Sponsors:
Clasado Research Services Ltd
Conditions:
Mild-to-Moderate Stress
Eligibility:
All Genders
25-40 years
Phase:
NA
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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06991023
Start Date
March 31 2025
End Date
February 1 2026
Last Update
January 8 2026
Active Locations (1)
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1
Nutrition, Cognition & Health Lab, School of Psychology and Clinical Language Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6ES