NCT07279454

The EAT-FIBRE Study.

The Eatwell Adapted Trial for Fibre Intervention in Bowel Cancer Risk Early-onset.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Microbiome Related Mechanisms Linked to Early Onset Colorectal Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-12-12
• Last updated: 2026-01-07

Locations

1 site across 1 country: United Kingdom