Traditional Dietary Advice Vs. Mediterranean Diet in IBS
Key facts
- Who runs it
- Sheffield Teaching Hospitals NHS Foundation Trust
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 139 people enrolled
- Started
- 30 Sept 2023
- Ended
- 20 Dec 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Traditional Diet
- Mediterranean Diet
- Record updated
- 14 March 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- IBS Symptom Severity Scale(IBS-SSS) > 75
- Online access
- English literate
Who cannot take part
- Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
- Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease, microscopic colitis, bile acid diarrhoea)
- History of eating disorder
- Severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating frequent medical consultations/hospitilisations
- Diabetes mellitus
- Memory impairment
- Body mass index <20
- Current dietary interventions
- Current use of opioids/antibiotics
- Titrating dose of neuromodulators
- Pregnant
- Scleroderma
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health impairment and healthcare utilization. Over 80% of individuals with IBS report food to trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current guidelines recommend first-line therapy with the relatively straightforward traditional dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line therapy.
Read full original descriptionShow less
There is emerging data suggesting that the Mediterranean diet may also improve the symptoms of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to help position it within the treatment algorithm. Given the relative ease of implementing the Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits, studying its efficacy in IBS is attractive as it could potentially pave the way for another first-line dietary option being available to patients before escalating to the demanding and resource intensive second-line therapies.
The investigators will perform a randomized trial comparing the clinical efficacy of traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization, participants will complete validated questionnaires to assess changes in IBS symptoms, quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction and adherence.
The 2 groups in the trial
- Traditional Dietary AdviceExisting treatment, for comparison
Its main elements are to adopt sensible eating habits and avoid excess fatty foods, spicy foods, processed foods, caffeine, fizzy drinks and alcohol.
Treatment: Traditional Diet
- Mediterranean DietExisting treatment, for comparison
The principle components is a diet rich in vegetables, pulses, whole grains, and olive oil
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome
- Record updated
- 14 March 2025