None listed
Conditions
Brief summary
Diet has potential to bridge the therapeutic gap in ulcerative colitis (UC). The proposed study evaluates a therapeutic diet for patients with mild-moderately UC. This diet will be tested in an 8-week randomised, placebo-controlled dietary advice study. Patients with mild-moderately active UC on stable therapy will be eligible for inclusion. Those eligible will be invited to provide informed consent then undertake baseline measurements including a 48-h stool collection, blood and urine sampling, clinical questionnaires, 7-day weighed food diary and a flexible sigmoidoscopy to confirm presence of inflammation. Participants will then be enrolled and undergo ingestion of a gas-sensing capsule before being randomised and blinded to receive one of two diets from a research dietitian. Meal plans and recipes will be provided along with a selection of food items. Participants will be reviewed at weeks 4 and 8, with repeating of baseline assessments at week 8.
Interventions
Therapeutic dietary advice followed for a period of 8 weeks - intervention diet and and placebo control sham diet.
Participants will receive a diet manual detailing the dietary prescription and accompanying food tables of foods to include and avoid, a 1-week set meal plan and an accompanying recipe book during a baseline dietary counselling with a research dietitian.
A selection of staple and non-staple food items will be provided and participants will receive a $400 financial contribution towar
Therapeutic dietary advice followed for a period of 8 weeks - intervention diet and and placebo control sham diet. Participants will receive a diet manual detailing the dietary prescription and accompanying food tables of foods to include and avoid, a 1-week set meal plan and an accompanying recipe book during a baseline dietary counselling with a research dietitian. A selection of staple and non-staple food items will be provided and participants will receive a $400 financial contribution towards shopping bills. A research dietitian will deliver 30-minutes of face to face dietary counselling. This will be provided face to face and phone support. This will occur at baseline, provide dietary support by phone at start of week 2 after transitioning off set meal plan, and 15 minutes of face to face dietary support at week 4 and 8. Face to face appointments will occur at the hospital. Dietary adherence will be monitored by self-reported pre-defined compliance categories and completion of 7-day weighed food diaries at weeks 0, 4, 8. The dietary intervention will be individualised to personal preference within the parameters of each dietary prescription during baseline dietary education, based on week 0 food diary information e.g. if a participant prefers soy milk to cows milk, this can be switched.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Greater than or equal to 18 years of age with a formal diagnosis of UC Mild-moderate UC disease activity as defined by a Total Mayo Score of 3-10 with a Mayo endoscopic sub-score of 1 or 2. Participants on stable therapy (or no therapy) for defined periods of time
Exclusion criteria
Quiescent UC disease activity as defined by a Total Mayo Score of less than or equal to 2 and/or a Mayo endoscopic sub-score of 0. Severely active UC as defined by a Total Mayo Score of greater than 10 and/or a Mayo endoscopic sub-score of 3 and/or evidence of systemic toxicity (tachycardia, fever, C-reactive protein greater than 40, Haemoglobin less than 110g/l). Pregnant Prior colonic surgery Crohn's colitis or indeterminate colitis Corticosteroid therapy (greater than or equal to 20mg oral corticosteroids or any dose IV corticosteroids) People who habitually follow a vegan or lacto-vegetarian diet Coeliac disease
Outcome results
None listed