Fibre and Mental Wellbeing Feasibility Trial

NCT ID: NCT06899607

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-09-05

Brief Summary

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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

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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.

Conditions

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Affect (Mental Function) Sleep Anxiety Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fibre arm

Group Type EXPERIMENTAL

Fibre arm

Intervention Type OTHER

Increasing daily fibre intake by 10 grams

Interventions

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Fibre arm

Increasing daily fibre intake by 10 grams

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Piril Hepsomali

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2025-037-PH

Identifier Type: -

Identifier Source: org_study_id

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