None listed
Conditions
Brief summary
Ulcerative colitis (UC) is a common debilitating chronic inflammatory bowel disease (IBD) of the large intestine, entailing inflammation and ulcerations in the lining of the large bowel. Recent research has shown that diet may play a role in contributing to the cause of gut inflammation involved in UC, and altering the diet may help manage UC. Therefore, we are investigating a new interventional diet to determine its clinical effects in UC. The results of this study will be able to help design dietary therapies to manage ulcerative colitis, especially as there is little information about the effect of diet on UC in humans. Hence, this study will conduct an 8-week dietary study, involving 4-weeks of feeding and 4-weeks of dietitian-led education, where participants with diagnosed mild-to-moderate UC will be randomly given 1 of 2 diets: the intervention diet or a sham diet. In study period 1 all meals, including breakfast, lunch and dinner, and snacks for each diet will be provided to the participant. In study period 2 participants will prepare their own suitable meals and snacks with dietary guidance from study dietitians. Blood and faecal samples will be collected, and participants will complete surveys to allow us to measure the effects of the new interventional diet on large bowel inflammation, changes in symptoms, quality of life and psychological well-being of UC, compared to the sham diet.
Interventions
There will be 2 dietary arms, each administered for 4-weeks.
The intervention arm is a diet low in sulphate-containing food additives. All food will be in collaboration with the study dietitian and provided to study participants for the duration of the study. The main meals will be delivered frozen to participants each week by an external meal delivery service. Examples of meals will include pasta, stir fry in rice. Participants will be instructed to consume only study meals provided and abstai
There will be 2 dietary arms, each administered for 4-weeks. The intervention arm is a diet low in sulphate-containing food additives. All food will be in collaboration with the study dietitian and provided to study participants for the duration of the study. The main meals will be delivered frozen to participants each week by an external meal delivery service. Examples of meals will include pasta, stir fry in rice. Participants will be instructed to consume only study meals provided and abstain from any food outside of the diet. The study will include 3 in-person study visits, each lasting approx 2 h, which will all be conducted and managed at the Alfred Hospital and Monash University that is co-located at the Alfred Research Alliance Precinct. The study visits will involve meeting with the principal investigator, study gastroenterologist and study dietitian (all of whom have more than 5 years experience). Instructions will be provided for compliance to the diet intervention. Adherence to the diets will be recorded in food diaries containing daily checkboxes to ensure participants are having the correct provided meals and an additional space to write down any meals or snacks ingested outside the diet.
Participants will be allocated to one of two dietary arms, each administered for up to 8 weeks across two consecutive 4-week periods. Period 1 will comprise a controlled feeding study in which all meals are provided. Period 2 will involve dietitian-led dietary education and support to facilitate continuation of the assigned diet. Participants will be asked to attend a final study visit 3-months post-study.
The intervention arm is a diet low in sulphate-containing food additives. During study pe
Participants will be allocated to one of two dietary arms, each administered for up to 8 weeks across two consecutive 4-week periods. Period 1 will comprise a controlled feeding study in which all meals are provided. Period 2 will involve dietitian-led dietary education and support to facilitate continuation of the assigned diet. Participants will be asked to attend a final study visit 3-months post-study. The intervention arm is a diet low in sulphate-containing food additives. During study period 1 all food will be in collaboration with the study dietitian and provided to study participants for the duration of the study. The main meals will be delivered frozen to participants each week by an external meal delivery service. Examples of meals will include pasta, stir fry in rice. Participants will be instructed to consume only study meals provided and abstain from any food outside of the diet. The study will include 5 in-person study visits, each lasting approx 2 h, which will be conducted and managed at either the Alfred Hospital or Box Hill Hospital (via Monash University that is co-located at the Alfred Research Alliance Precinct and Eastern Health Clinical School). The study visits will involve meeting with the principal investigator, study gastroenterologist and study dietitian (all of whom have more than 5 years experience). Instructions will be provided for compliance to the diet intervention. During both study periods, dietary adherence will be monitored using food diaries containing daily checkboxes to confirm consumption of the provided meals during Period 1, or preparation and consumption of suitable meals/foods during Period 2. The food diaries will also include space for participants to record any foods or snacks consumed outside of the prescribed diet.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- mild to moderate ulcerative colitis - active disease (either left-sided or extensive UC) as evidenced sonographically, faecal calprotectin >250 and where available, endoscopy results performed in the last 3 months indicate total Mayo score of 3-10 - on stable medical therapy for >1 month - naïve to formal dietetic intervention
Exclusion criteria
- Severe UC, indeterminate colitis or Crohn’s disease - Presence of other GI co-morbidities (e.g. coeliac disease) - Presence of clinically significant haematological abnormalities - Prior gastrointestinal surgeries - Pregnancy, trying to get pregnant and breastfeeding - Current use of corticosteroids - Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (e.g. food allergy, veganism, lacto-ovo vegetarianism) - Individuals not on a stable diet for at least 4 weeks
Outcome results
None listed