The EAT-FIBRE Study.

NCT07279454 | Not Yet Recruiting

• 1 other identifier: 24/NW/0107
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Microbiome Related Mechanisms Linked to Early Onset Colorectal Cancer

Keywords

diet; fibre; EatWell; randomised controlled trial; microbiome; short-chain fatty acids; inflammation; twins

Outcome Measures

Primary Outcomes (1)

• Short Chain Fatty Acids

  Change from baseline in faecal butyrate.

  12 weeks; from baseline to endpoint.

Secondary Outcomes (3)

• Microbially derived metabolites

  12 weeks; from baseline to endpoint.

• Gut microbiome composition

  12 weeks; from baseline to endpoint.

• Markers of systemic and intestinal inflammation

  12 weeks; from baseline to endpoint.

Other Outcomes (4)

• Biomarkers of intestinal function

  12 weeks; from baseline to endpoint.

• Prostaglandin E2

  12 weeks; from baseline to endpoint.

• Markers of cardiometabolic health

  12 weeks; from baseline to endpoint.

Study Arms (2)

EatWell diet

ACTIVE COMPARATOR

Participants will be advised to follow the EatWell diet (UK national healthy eating guidance), providing 30g/day of dietary fibre.

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.

Other: Modified EatWell diet

Interventions

Modified EatWell diet OTHER

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.

Modified EatWell diet

EatWell diet OTHER

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.

EatWell diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Cancer Research UK: collaborator
• Bowelbabe Fund: collaborator
• National Cancer Institute (NCI): collaborator
• National Cancer Institute, France: collaborator

Study Sites (1)

Department of Twin Research and Genetics

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jordana Bell, Professor

  King's College London Twin Research & Genetic Epidemiology

  PRINCIPAL INVESTIGATOR

• Sarah Berry, Professor

  King's College London Department of Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvia Zanesco Zanesco, Dr

CONTACT

020 7848 4444; sylvia.1.zanesco@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-11

Locations

GB (1)