Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06899607

Fibre and Mental Wellbeing Feasibility Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Affect (Mental Function) Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Sleep Stress

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6ES, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibre arm

Other

Increasing daily fibre intake by 10 grams

Primary outcomes

  1. Generalized Anxiety Disorder 7 scale scores

    Time frame: From baseline (pre intervention) to week 2 (post intervention)

    A validated self-report measure of anxiety

  2. Patient Health Questionaire-8 scores

    Time frame: From baseline (pre intervention) to week 2 (post intervention)

    A validated self-report measure of depression

  3. Perceived Stress Scale scores

    Time frame: From baseline (pre intervention) to week 2 (post intervention)

    A validated self-report measure of stress

Secondary outcomes

  1. Pittsburgh Sleep Quality Index scores

    Time frame: From baseline (pre intervention) to week 2 (post intervention)

    A validated self-report measure of sleep quality

  2. 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)

  3. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.