Microbiome Related Mechanisms Linked to Early Onset Colorectal CancerEAT-FIBRENCT07279454
The EAT-FIBRE Study.
A study testing Modified EatWell diet and EatWell diet in people with Microbiome Related Mechanisms Linked to Early Onset Colorectal Cancer, run by King's College London at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to understand whether diet can impact mechanisms linked to early-onset colorectal cancer. The main question it aims to answer is: does a high-fibre modified EatWell diet improve stool, blood, urine, and saliva measures linked to early-onset colorectal cancer, compared to the standard… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiome Related Mechanisms Linked to Early Onset Colorectal Cancer
- What is being tested?
- Modified EatWell diet and EatWell diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2026to Dec 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- If female, not pregnant, lactating, or planning a pregnancy within the next 4 months.
- Living in the United Kingdom.
Who cannot join
- Dietary fibre intake <16 g/day or >30 g/day.
- Unwilling to comply with the intervention (wholegrains, beans and pulses, and nuts and seeds).
- Are diagnosed with the following food allergies: gluten, peanuts, or nuts.
- Are living or have a past medical history of an eating disorder.
- Alcohol Use Disorders Identification Test - Consumption score > 10 points.
- Have lost significant weight (>10% of original bodyweight) over the past 3 months.
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- Use of any of the following drugs within the last month:
- antifungals, antivirals, or antiparasitic medications (ii) methotrexate or immunosuppressive agents.
- Use of systemic antibiotics within the last 3 months.
- Use of commercial probiotics, prebiotics, laxatives, or other gut health supplements within the last month.
- Using Glucagon-Like Peptide-1 Receptor Agonists.
- Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- Undergoing dietetic care for chronic conditions.
- History of cancer, except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired), including human immunodeficiency virus infection.
- Major surgery of the GI tract, except for cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- Any other condition declared by the participant deemed by the medical supervisor to affect the normal conduct of the study and analysis of results.
- History of active, uncontrolled gastrointestinal disorders or diseases, including:
- Coeliac disease (ii) inflammatory bowel disease, including ulcerative colitis, Crohn's disease, or indeterminate colitis (iii) persistent, infectious gastroenteritis, colitis or gastritis (iv) persistent or chronic diarrhoea of unknown aetiology (v) chronic constipation (vi) Irritable Bowel Syndrome (vii) Clostridium difficile infection (recurrent) (viii) Helicobacter pylori infection (untreated).
- Any other condition declared by the participant deemed by the medical supervisor to affect the normal conduct of the study and analysis of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Department of Twin Research and Genetics
London, SE1 7EH
Aryun Nessa, 00442071887188 ext. 52832, ayrun.nessa@kcl.ac.uk
About this study
Official title: The Eatwell Adapted Trial for Fibre Intervention in Bowel Cancer Risk Early-onset.
The goal of this clinical trial is to understand whether diet can impact mechanisms linked to early-onset colorectal cancer.
The main question it aims to answer is: does a high-fibre modified EatWell diet improve stool, blood, urine, and saliva measures linked to early-onset colorectal cancer, compared to the standard EatWell diet?
Read more
Researchers will compare the standard EatWell diet (UK national healthy eating guidance providing 30g/day of dietary fibre) to a modified EatWell diet (UK national healthy eating guidance plus specific thresholds for fibre-rich food groups providing 40g/day of dietary fibre).
Participants will follow the dietary advice for 12 weeks, attend clinic visits at the start and end of the study for stool, blood, urine, and saliva sampling, body composition measures, health checks, and complete health, diet, and lifestyle questionnaires.
Read the detailed description
BACKGROUND The incidence of early-onset colorectal cancer (EOCRC) is on the rise worldwide. Many EOCRC cases may be preventable through modifiable lifestyle factors, including diet . Colorectal cancer risk reductions have been reported with higher intakes of dietary fibre, and different food sources of fibre may confer varying levels of protection. Dietary recommendations for colorectal cancer prevention advise limiting the intake of red and processed meats and added sugars, while prioritising fibre-rich foods such as fruits, vegetables, and whole grains, aligning with the UK EatWell diet; however, its effects on mechanisms underlying EOCRC remain to be elucidated.
AIM To evaluate whether a modified high-fibre EatWell diet can more effectively modulate metabolomic, microbiome, and inflammatory markers associated with EOCRC compared to the standard EatWell diet.
PARTICIPANTS One hundred adult twin pairs (n=200), volunteers of TwinsUK, will be invited to participate. Interested individuals will complete a screening survey and a food frequency questionnaire to determine eligibility.
METHODS EAT-FIBRE is a single-centre parallel-arm randomised controlled diet intervention trial. Twin pairs will be split-randomised with allocation to either the control arm (standard EatWell diet) or intervention arm (modified EatWell diet) to adhere to for 12 weeks. Participants will attend the clinic for stool, blood, urine, and saliva sampling, body composition measures, health checks, and complete health, diet, and lifestyle questionnaires, and will return at the endpoint for repeat measures. The follow-up will be remote at 12 months, where participants will collect and post stool, blood, urine, and saliva samples, and repeat various questionnaires.
- Being tested
- Modified EatWell diet, EatWell diet
- Keywords
- diet, fibre, EatWell, randomised controlled trial, microbiome, short-chain fatty acids, inflammation, twins
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified EatWell dietOther
5-a-day for fruits and vegetables, <70g/day of red meat, 2 portions of fish/week (one of which is oily), <14 units of alcohol/week, plus specific daily thresholds of 180g/day (cooked) of wholegrain cereals, 160g/day (cooked) of beans and pulses, and 30g/day of nuts and seeds.
Total dietary fibre = 40g/day.
EatWell dietOther
5-a-day for fruits and vegetables, <70g/day of red meat, 2 portions of fish/week (one of which is oily), and <14 units of alcohol/week. No specific daily thresholds for wholegrain cereals, beans and pulses, or nuts and seeds will be provided.
Total dietary fibre = 30g/day.
| Study group | Role | What they receive |
|---|---|---|
| EatWell diet | Active comparator | Participants will be advised to follow the EatWell diet (UK national healthy eating guidance), providing 30g/day of dietary fibre. Receives: Other: EatWell diet |
| Modified EatWell diet | Experimental | Participants will be advised to follow the EatWell diet (UK national healthy eating guidance) with additional daily thresholds for fibre-rich food groups (wholegrain cereals, beans and pulses, and nuts and seeds), providing 40g/day of dietary fibre. Receives: Other: Modified EatWell diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Chain Fatty Acids
Change from baseline in faecal butyrate.
Measured: 12 weeks; from baseline to endpoint.
Secondary outcomes (3)
Microbially derived metabolites
Change from baseline in faecal and circulating levels of microbially derived metabolites, including other SCFAs and bile acids.
Measured: 12 weeks; from baseline to endpoint.
Gut microbiome composition
Change from baseline in faecal microbial community composition.
Measured: 12 weeks; from baseline to endpoint.
Markers of systemic and intestinal inflammation
Change from baseline in circulating levels of inflammatory markers, including cytokines, and faecal levels of calprotectin and myeloperoxidase.
Measured: 12 weeks; from baseline to endpoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiome Related Mechanisms Linked to Early Onset Colorectal CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, National Cancer Institute (NCI), Bowelbabe Fund, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Jordana Bell, Professor, Principal investigator, King's College London Twin Research & Genetic EpidemiologySarah Berry, Professor, Principal investigator, King's College London Department of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279454
- Sponsor's protocol ID
- 24/NW/0107
- Acronym
- EAT-FIBRE
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Eatwell Adapted Trial for Fibre Intervention in Bowel Cancer Risk Early-onset.
- ClinicalTrials.gov ID
- NCT07279454
- Acronym / sponsor ID
- EAT-FIBRE / 24/NW/0107
- Keywords
- diet, fibre, EatWell, randomised controlled trial, microbiome, short-chain fatty acids, inflammation, twins
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, National Cancer Institute (NCI), Bowelbabe Fund, National Cancer Institute, France
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Dec 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.
The goal of this clinical trial is to understand whether diet can impact mechanisms linked to early-onset colorectal cancer.
The main question it aims to answer is: does a high-fibre modified EatWell diet improve stool, blood, urine, and saliva measures linked to early-onset colorectal cancer, compared to the standard EatWell diet?
Researchers will compare the standard EatWell diet (UK national healthy eating guidance providing 30g/day of dietary fibre) to a modified EatWell diet (UK national healthy eating guidance plus specific thresholds for fibre-rich food groups providing 40g/day of dietary fibre).
Participants will follow the dietary advice for 12 weeks, attend clinic visits at the start and end of the study for stool, blood, urine, and saliva sampling, body composition measures, health checks, and complete health, diet, and lifestyle questionnaires.
Detailed description
BACKGROUND The incidence of early-onset colorectal cancer (EOCRC) is on the rise worldwide. Many EOCRC cases may be preventable through modifiable lifestyle factors, including diet . Colorectal cancer risk reductions have been reported with higher intakes of dietary fibre, and different food sources of fibre may confer varying levels of protection. Dietary recommendations for colorectal cancer prevention advise limiting the intake of red and processed meats and added sugars, while prioritising fibre-rich foods such as fruits, vegetables, and whole grains, aligning with the UK EatWell diet; however, its effects on mechanisms underlying EOCRC remain to be elucidated.
AIM To evaluate whether a modified high-fibre EatWell diet can more effectively modulate metabolomic, microbiome, and inflammatory markers associated with EOCRC compared to the standard EatWell diet.
PARTICIPANTS One hundred adult twin pairs (n=200), volunteers of TwinsUK, will be invited to participate. Interested individuals will complete a screening survey and a food frequency questionnaire to determine eligibility.
METHODS EAT-FIBRE is a single-centre parallel-arm randomised controlled diet intervention trial. Twin pairs will be split-randomised with allocation to either the control arm (standard EatWell diet) or intervention arm (modified EatWell diet) to adhere to for 12 weeks. Participants will attend the clinic for stool, blood, urine, and saliva sampling, body composition measures, health checks, and complete health, diet, and lifestyle questionnaires, and will return at the endpoint for repeat measures. The follow-up will be remote at 12 months, where participants will collect and post stool, blood, urine, and saliva samples, and repeat various questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EatWell diet | Active comparator | Other: EatWell dietParticipants will be advised to follow the EatWell diet (UK national healthy eating guidance), providing 30g/day of dietary fibre. |
| Modified EatWell diet | Experimental | Other: Modified EatWell dietParticipants will be advised to follow the EatWell diet (UK national healthy eating guidance) with additional daily thresholds for fibre-rich food groups (wholegrain cereals, beans and pulses, and nuts and seeds), providing 40g/day of dietary fibre. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- If female, not pregnant, lactating, or planning a pregnancy within the next 4 months.
- Living in the United Kingdom.
Key exclusion criteria (20 listed)
- Dietary fibre intake <16 g/day or >30 g/day.
- Unwilling to comply with the intervention (wholegrains, beans and pulses, and nuts and seeds).
- Are diagnosed with the following food allergies: gluten, peanuts, or nuts.
- Are living or have a past medical history of an eating disorder.
- Alcohol Use Disorders Identification Test - Consumption score > 10 points.
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 |
|---|---|---|
| Modified EatWell diet5-a-day for fruits and vegetables, <70g/day of red meat, 2 portions of fish/week (one of which is oily), <14 units of alcohol/week, plus specific daily thresholds of 180g/day (cooked) of wholegrain cereals, 160g/day (cooked) of beans and pulses, and 30g/day of nuts and seeds. Total dietary fibre = 40g/day. | Other | Modified EatWell diet |
| EatWell diet5-a-day for fruits and vegetables, <70g/day of red meat, 2 portions of fish/week (one of which is oily), and <14 units of alcohol/week. No specific daily thresholds for wholegrain cereals, beans and pulses, or nuts and seeds will be provided. Total dietary fibre = 30g/day. | Other | EatWell diet |
Primary outcome
Short Chain Fatty Acids
Time frame: 12 weeks; from baseline to endpoint.
Change from baseline in faecal butyrate.
3 secondary outcomes
Microbially derived metabolites
Time frame: 12 weeks; from baseline to endpoint.
Gut microbiome composition
Time frame: 12 weeks; from baseline to endpoint.
Markers of systemic and intestinal inflammation
Time frame: 12 weeks; from baseline to endpoint.
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 7 Jan 2026.
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.
Jordana Bell, Professor principal investigator
King's College London Twin Research & Genetic Epidemiology
Sarah Berry, Professor principal investigator
King's College London Department of Nutritional Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified EatWell diet and EatWell diet in people with Microbiome Related Mechanisms Linked to Early Onset Colorectal Cancer, run by King's College London 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 2 inclusion and 20 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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?
Contact Sylvia Zanesco Zanesco, Dr (020 7848 4444, sylvia.1.zanesco@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Chain Fatty Acids (time frame: 12 weeks; from baseline to endpoint.). 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 7 Jan 2026.