Affect (Mental Function)NCT06899607
Fibre and Mental Wellbeing Feasibility Trial
A study testing Fibre arm in people with Affect (Mental Function) and Sleep, run by University of Reading at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Affect (Mental Function), Sleep, Anxiety
- What is being tested?
- Fibre arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 5 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, RG6 6ES
About this study
Official title: Bridging the Fibre Gap: A Pre-post Single-arm Feasibility Trial on Increased Fibre Intake and Mental Wellbeing
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.
- Conditions
- Affect (Mental Function), Sleep, Anxiety, Stress
- Being tested
- Fibre arm
- Keywords
- fibre, depression, anxiety, stress, optimism, sleep, gut health
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibre armOther
Increasing daily fibre intake by 10 grams
| Study group | Role | What they receive |
|---|---|---|
| Fibre arm | Experimental | Not described Receives: Other: Fibre arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder 7 scale scores
A validated self-report measure of anxiety
Measured: From baseline (pre intervention) to week 2 (post intervention)
Patient Health Questionaire-8 scores
A validated self-report measure of depression
Measured: From baseline (pre intervention) to week 2 (post intervention)
Perceived Stress Scale scores
A validated self-report measure of stress
Measured: From baseline (pre intervention) to week 2 (post intervention)
Secondary outcomes (3)
Pittsburgh Sleep Quality Index scores
A validated self-report measure of sleep quality
Measured: From baseline (pre intervention) to week 2 (post intervention)
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)
Measured: From baseline (pre intervention) to week 2 (post intervention)
Revised Life Orientation Test Scores
A validated self-report measure of one's dispositional level of optimism
Measured: From baseline (pre intervention) to week 2 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 May 2025
- Primary completion5 Sep 2027 (estimated)
- Study completion5 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affect (Mental Function)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piril Hepsomali, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899607
- Sponsor's protocol ID
- 2025-037-PH
- Status last verified
- Dec 2025
- First submitted
- 25 Mar 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Fibre Gap: A Pre-post Single-arm Feasibility Trial on Increased Fibre Intake and Mental Wellbeing
- ClinicalTrials.gov ID
- NCT06899607
- Acronym / sponsor ID
- 2025-037-PH
- Conditions
- Affect (Mental Function), Sleep, Anxiety, Stress
- Keywords
- fibre, depression, anxiety, stress, optimism, sleep, gut health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 5 Sep 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibre arm | Experimental | Other: Fibre arm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibre armIncreasing daily fibre intake by 10 grams | Other | Fibre arm |
Primary outcome
Generalized Anxiety Disorder 7 scale scores
Time frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of anxiety
Patient Health Questionaire-8 scores
Time frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of depression
Perceived Stress Scale scores
Time frame: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of stress
3 secondary outcomes
Pittsburgh Sleep Quality Index scores
Time frame: From baseline (pre intervention) to week 2 (post intervention)
Gastrointestinal Symptom Rating Scale Scores
Time frame: From baseline (pre intervention) to week 2 (post intervention)
Revised Life Orientation Test Scores
Time frame: From baseline (pre intervention) to week 2 (post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibre arm in people with Affect (Mental Function) and Sleep, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder 7 scale scores (time frame: From baseline (pre intervention) to week 2 (post intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.