The EAT-FIBRE Study. (EAT-FIBRE)

January 5, 2026 updated by: King's College London

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?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion

  • If female, not pregnant, lactating, or planning a pregnancy within the next 4 months.
  • Living in the United Kingdom.

Exclusion

  • 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.

  • Use of any of the following drugs within the last month:

    (i) 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:

    (i) 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EatWell diet
Participants will be advised to follow the EatWell diet (UK national healthy eating guidance), providing 30g/day of dietary fibre.
Other: EatWell diet

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.
Experimental: Modified EatWell diet
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.
Other: Modified EatWell diet

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Chain Fatty Acids
Time Frame: 12 weeks; from baseline to endpoint.
Change from baseline in faecal butyrate.
12 weeks; from baseline to endpoint.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbially derived metabolites
Time Frame: 12 weeks; from baseline to endpoint.
Change from baseline in faecal and circulating levels of microbially derived metabolites, including other SCFAs and bile acids.
12 weeks; from baseline to endpoint.
Gut microbiome composition
Time Frame: 12 weeks; from baseline to endpoint.
Change from baseline in faecal microbial community composition.
12 weeks; from baseline to endpoint.
Markers of systemic and intestinal inflammation
Time Frame: 12 weeks; from baseline to endpoint.
Change from baseline in circulating levels of inflammatory markers, including cytokines, and faecal levels of calprotectin and myeloperoxidase.
12 weeks; from baseline to endpoint.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of intestinal function
Time Frame: 12 weeks; from baseline to endpoint.
Changes from baseline in markers of intestinal barrier function, including faecal levels of mucin-2 and circulating levels of intestinal fatty acid binding protein.
12 weeks; from baseline to endpoint.
Prostaglandin E2
Time Frame: 12 weeks; from baseline to endpoint.
Change from baseline in urinary prostaglandin E2.
12 weeks; from baseline to endpoint.
Markers of cardiometabolic health
Time Frame: 12 weeks; from baseline to endpoint.
Change from baseline in circulating levels of individual markers related to cardiometabolic health, including glucose measured in mmol/L, and lipids measured in mmol/L.
12 weeks; from baseline to endpoint.
Anthropometry
Time Frame: 12 weeks; from baseline to endpoint.
Change from baseline in body composition, including weight in kilograms, height in meters for Body Mass Index (kg/m2) and adiposity measures, including % fat mass.
12 weeks; from baseline to endpoint.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

National Cancer Institute (NCI)
Cancer Research UK
National Cancer Institute, France
Bowelbabe Fund

Investigators

  • Principal Investigator: Jordana Bell, Professor, King's College London Twin Research & Genetic Epidemiology
  • Principal Investigator: Sarah Berry, Professor, King's College London Department of Nutritional Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Estimated)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24/NW/0107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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