Fibre and Mental Wellbeing Feasibility Trial

December 2, 2025 updated by: Piril Hepsomali, University of Reading

Bridging the Fibre Gap: A Pre-post Single-arm Feasibility Trial on Increased Fibre Intake and Mental Wellbeing

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The current pre-post single-arm feasibility trial will investigate whether increasing daily fibre intake by 10 grams for two weeks enhance depression, anxiety, stress, sleep quality, gut health, and optimism in 18-40 year-old young adults. Participants will be provided a list of high fibre food items. Outcome measures will be acquired before and after 2-weeks . These will include cognitive measures of measures of depression, anxiety, and stress symptomatology; sleep; gastrointestinal symptomatology; optimism.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6ES
        • University of Reading, School of Psychology and Clinical Languages

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fibre arm
Other: Fibre arm
Increasing daily fibre intake by 10 grams

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder 7 scale scores
Time Frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of anxiety
From baseline (pre intervention) to week 2 (post intervention)
Patient Health Questionaire-8 scores
Time Frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of depression
From baseline (pre intervention) to week 2 (post intervention)
Perceived Stress Scale scores
Time Frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of stress
From baseline (pre intervention) to week 2 (post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index scores
Time Frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of sleep quality
From baseline (pre intervention) to week 2 (post intervention)
Gastrointestinal Symptom Rating Scale Scores
Time Frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of gastrointestinal symptoms that includes 15-items (combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation)
From baseline (pre intervention) to week 2 (post intervention)
Revised Life Orientation Test Scores
Time Frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of one's dispositional level of optimism
From baseline (pre intervention) to week 2 (post intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EPIC Norfolk Food Frequency Questionnaire (FFQ)
Time Frame: Baseline (pre intervention) only
The FFQ is a validated tool for gauging the average habitual dietary intake of micro and macronutrients of an individual in the UK. Data will be processed using the FETA software.
Baseline (pre intervention) only
FiberScreen Scores
Time Frame: From baseline (pre intervention) to week 2 (post intervention)
A questionnaire that assesses fibre intake. It will be used to screen participants. Individuals who adhere to a high fibre diet (>20g fibre/day) will be excluded from the study.
From baseline (pre intervention) to week 2 (post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

September 5, 2027

Study Completion (Estimated)

September 5, 2027

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-037-PH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress

Clinical Trials on Fibre arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe