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Clinical Trials/ACTRN12617000795392
ACTRN12617000795392
Completed
未知

A randomised controlled trial of the effects of dietary prebiotic foods and probiotic supplements on mental health and cognition in adults with subclinical depression and/or anxiety: The Gut Feelings trial

The University of Melbourne0 sites119 target enrollmentMay 31, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
The University of Melbourne
Enrollment
119
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 31, 2017
End Date
September 17, 2019
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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