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Fibre and Mental Wellbeing Feasibility Trial

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06899607
Enrollment
40
Registered
2025-03-28
Start date
2025-05-01
Completion date
2027-09-05
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affect (Mental Function), Anxiety, Sleep, Stress

Keywords

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

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.

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.

Interventions

Increasing daily fibre intake by 10 grams

Sponsors

University of Reading
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Generalized Anxiety Disorder 7 scale scoresFrom baseline (pre intervention) to week 2 (post intervention)A validated self-report measure of anxiety
Patient Health Questionaire-8 scoresFrom baseline (pre intervention) to week 2 (post intervention)A validated self-report measure of depression
Perceived Stress Scale scoresFrom baseline (pre intervention) to week 2 (post intervention)A validated self-report measure of stress

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index scoresFrom baseline (pre intervention) to week 2 (post intervention)A validated self-report measure of sleep quality
Gastrointestinal Symptom Rating Scale ScoresFrom 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)
Revised Life Orientation Test ScoresFrom baseline (pre intervention) to week 2 (post intervention)A validated self-report measure of one's dispositional level of optimism

Other

MeasureTime frameDescription
EPIC Norfolk Food Frequency Questionnaire (FFQ)Baseline (pre intervention) onlyThe 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.
FiberScreen ScoresFrom 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026