Clinical trial · Interventional
The EAT-FIBRE Study.
The Eatwell Adapted Trial for Fibre Intervention in Bowel Cancer Risk Early-onset.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Microbiome Related Mechanisms Linked to Early Onset Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EatWell diet | Other | — | UNRESOLVED |
| Modified EatWell diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EatWell diet
- description
- Participants will be advised to follow the EatWell diet (UK national healthy eating guidance), providing 30g/day of dietary fibre.
- interventionNames
- Other: EatWell diet
- type
- EXPERIMENTAL
- label
- Modified EatWell diet
- description
- 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.
- interventionNames
- Other: Modified EatWell diet
Primary outcomes (1)
- measure
- Short Chain Fatty Acids
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available