Clinical trial NCT06899607: Fibre and Mental Wellbeing Feasibility Trial
Official title: Bridging the Fibre Gap: A Pre-post Single-arm Feasibility Trial on Increased Fibre Intake and Mental Wellbeing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Affect (Mental Function)
Sleep
Anxiety
Stress
Keywords: fibre
depression
anxiety
stress
optimism
sleep
gut health
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Generalized Anxiety Disorder 7 scale scores
timeFrame: From baseline (pre intervention) to week 2 (post intervention)
measure: Patient Health Questionaire-8 scores
timeFrame: From baseline (pre intervention) to week 2 (post intervention)
measure: Perceived Stress Scale scores
timeFrame: From baseline (pre intervention) to week 2 (post intervention)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index scores
timeFrame: From baseline (pre intervention) to week 2 (post intervention)
measure: Gastrointestinal Symptom Rating Scale Scores
timeFrame: From baseline (pre intervention) to week 2 (post intervention)
measure: Revised Life Orientation Test Scores
timeFrame: From baseline (pre intervention) to week 2 (post intervention)
Other outcomes:
measure: EPIC Norfolk Food Frequency Questionnaire (FFQ)
timeFrame: Baseline (pre intervention) only
measure: FiberScreen Scores
timeFrame: From baseline (pre intervention) to week 2 (post intervention)
Locations:
city: Reading
country: United Kingdom
facility: University of Reading, School of Psychology and Clinical Languages
state: Berkshire
Study officials:
References: