CClinicalTrials.gg
Active, not recruitingNCT06899607Updated Dec 3, 2025

Fibre and Mental Wellbeing Feasibility Trial

An interventional study of Fibre arm in Affect (Mental Function), Sleep and Anxiety, sponsored by University of Reading. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by University of Reading · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Affect (Mental Function)
  • Sleep
  • Anxiety
  • Stress

Keywords

  • fibre
  • depression
  • anxiety
  • stress
  • optimism
  • sleep
  • gut health
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Reading is the lead sponsor of 146 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Fibre arm

    Other: Fibre arm

Interventions

  • OtherFibre arm

    Increasing daily fibre intake by 10 grams

06

What researchers measure

Primary outcomes

  1. Generalized Anxiety Disorder 7 scale scores

    A validated self-report measure of anxiety

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

  2. Patient Health Questionaire-8 scores

    A validated self-report measure of depression

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

  3. Perceived Stress Scale scores

    A validated self-report measure of stress

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

Secondary outcomes

  1. Pittsburgh Sleep Quality Index scores

    A validated self-report measure of sleep quality

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

  2. Gastrointestinal Symptom Rating Scale Scores

    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)

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

  3. Revised Life Orientation Test Scores

    A validated self-report measure of one's dispositional level of optimism

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

Other outcomes

  1. EPIC Norfolk Food Frequency Questionnaire (FFQ)

    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.

    Time frame: Baseline (pre intervention) only

  2. FiberScreen Scores

    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.

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

07

Study locations

1 site
  • University of Reading, School of Psychology and Clinical Languages
    Reading, Berkshire RG6 6ES, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06899607
Lead sponsor
University of Reading
Responsible party
Piril Hepsomali (Principle Investigator, University of Reading) — Principal investigator
First posted
Mar 28, 2025
Start date
May 1, 2025
Primary completion
Sep 5, 2027 (estimated)
Completion
Sep 5, 2027 (estimated)
Last update
Dec 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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