FD-ULTRA
Research type
Research Study
Full title
A prospective, pragmatic, pilot study to quantify the degree of ultra-processed food intake in patients with functional dyspepsia, and assess the impact of a minimally processed food diet as a treatment modality
IRAS ID
348984
Contact name
Pushpsen Joshi
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2024/10/124, UCL Data Protection Registration Number
Duration of Study in the UK
1 years, 4 months, 2 days
Research summary
Functional dyspepsia (FD) is a common condition that causes discomfort in the upper part of the tummy. People with FD usually get symptoms of pain, bloating, and feeling of fullness, which can affect a person’s ability to carry out normal daily routines. The main treatment for FD is with medications, but these only offer partial relief and do not work in all people. Although different foods have been implicated in FD, the role of using special diets to treat FD is very poorly researched and recommendations are inconsistent. Recently there has been growing concern about the impact of ultra-processed foods (UPF) on health, including digestive conditions like FD. UPFs are foods that have been heavily altered through industrial processing and often contain additives, preservatives, and artificial flavours. In this study, we want to see whether people with FD have a high intake of UPF in their diet. This will help us understand whether high UPF intake is common among patients with FD. Among those with FD who consume a high proportion of UPF in their daily diet, we want to then explore whether switching to a minimally processed food (MPF) diet can improve their symptoms. We will combine a MPF diet with a behavioural support programme to empower people to make, and sustain, healthy food choices. We will then track changes in symptoms, quality of life, and other health markers over six months to see whether a MPF diet can make a positive impact of their health. The results of this study will help us determine if reducing UPF intake can be an effective treatment for patients with FD.
REC name
North West - Preston Research Ethics Committee
REC reference
25/NW/0055
Date of REC Opinion
18 Mar 2025
REC opinion
Further Information Favourable Opinion