Fibre and Mental Wellbeing Feasibility Trial

NCT06899607 | Active Not Recruiting

• 1 other identifier: 2025-037-PH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will explore whether adding an extra 10 grams of fibre to participants' daily diet for two weeks would improve their mental health and wellbeing.

Conditions

Sleep; Affect (Mental Function); Anxiety; Stress

Keywords

fibre; depression; anxiety; stress; optimism; sleep; gut health

Outcome Measures

Primary Outcomes (3)

• Generalized Anxiety Disorder 7 scale scores

  A validated self-report measure of anxiety

  From baseline (pre intervention) to week 2 (post intervention)

• Patient Health Questionaire-8 scores

  A validated self-report measure of depression

  From baseline (pre intervention) to week 2 (post intervention)

• Perceived Stress Scale scores

  A validated self-report measure of stress

  From baseline (pre intervention) to week 2 (post intervention)

Secondary Outcomes (3)

• Pittsburgh Sleep Quality Index scores

  From baseline (pre intervention) to week 2 (post intervention)

• Gastrointestinal Symptom Rating Scale Scores

  From baseline (pre intervention) to week 2 (post intervention)

• Revised Life Orientation Test Scores

  From baseline (pre intervention) to week 2 (post intervention)

Other Outcomes (2)

• EPIC Norfolk Food Frequency Questionnaire (FFQ)

  Baseline (pre intervention) only

• FiberScreen Scores

  From baseline (pre intervention) to week 2 (post intervention)

Study Arms (1)

Fibre arm

EXPERIMENTAL

Other: Fibre arm

Interventions

Fibre arm OTHER

Increasing daily fibre intake by 10 grams

Fibre arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aging between 18-40 years old
• Having normal vision and hearing
• Having a body mass index between 18.5 and 30
• Not following a high fibre diet \>20g fibre/day as assessed by using the FiberScreen

You may not qualify if:

• Smoking
• Having food allergies
• Following restrictive and/or unbalanced diets
• Changing dietary intake majorly in past month
• Being diagnosed with any psychiatric or neurologic conditions
• Being diagnosed with any cardiometabolic diseases, or hypertension or thrombosis related disorders or suffer from thyroid disease
• Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
• Currently consuming prebiotic or probiotic supplements or laxatives
• Continuous antibiotic use for \> 3 days within 1 month prior to enrolment
• Continuous use of weight-loss drug for \> 1 month before screening
• Having a significant gastrointestinal (GI) condition

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6ES, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: March 28, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 5, 2027
• Study Completion (Estimated): September 5, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)