A randomised controlled trial of the effects of dietary prebiotic foods and probiotic supplements on adult mental health and cognition: The Gut Feelings trial

Not Applicable

Completed

• Conditions: Depression; Anxiety; Stress; Mental Health - Studies of normal psychology, cognitive function and behaviour; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12617000795392
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-31
• Study Completion: 2019-09-17
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Prebiotic fibre intake of <3 grams/day, as measured by a purpose-built Dietary Screener, to ensure that there is sufficient scope for improvement in diet
- Subclinical levels of anxiety and/or depression. Eligible participants must score 16-26 on the Kessler Psychological Distress Scale (K10)
- Free of psychiatric medications for > 4 weeks

Exclusion Criteria

- Ingestion of fermented foods or probiotic supplements within past 2 weeks
- Substance dependence within the previous month
- BMI over 35
- Fulfils diagnostic criteria for a clinical mental illness
- Currently taking medication with primarily CNS activity
- Pregnancy
- Irritable bowel syndrome or chronic constipation, and FODMAP-sensitive individuals
- Taking antibiotics, proton pump inhibitors, non-steroid anti-inflammatory drugs (any amount greater than 3 doses per month), or immunocompromising medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified