Fibre and Mental Wellbeing Feasibility Trial

Not Applicable

Recruiting

• Conditions: Affect (Mental Function); Sleep; Anxiety; Stress

• Registration Number: NCT06899607
• Lead Sponsor: University of Reading

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.

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-03-28
• Study Start: 2025-05-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-10
• Primary Completion: 2025-09-05
• Study Completion: 2025-09-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index scores	From baseline (pre intervention) to week 2 (post intervention)	A validated self-report measure of sleep quality
Gastrointestinal Symptom Rating Scale Scores	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)
Revised Life Orientation Test Scores	From baseline (pre intervention) to week 2 (post intervention)	A validated self-report measure of one's dispositional level of optimism

Trial Locations

Locations (1)

University of Reading, School of Psychology and Clinical Languages; 🇬🇧 Reading, Berkshire, United Kingdom