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NOT YET RECRUITING

NCT07279454

The EAT-FIBRE Study.

Sponsor: King's College London

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-01

Completion Date

2027-12

Last Updated

2026-01-07

Healthy Volunteers

Yes

Conditions

Interventions

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.

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.

Locations (1)

Department of Twin Research and Genetics

London, United Kingdom