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The role of a low emulsifier diet in treating Crohn’s disease - Study 2

The role of a low emulsifier diet in treating intestinal inflammation in patients with Crohn’s disease

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001099112
Enrollment
22
Registered
2019-08-09
Start date
2023-03-15
Completion date
2024-03-15
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

It is hypothesised that removal of dietary emulsifiers, which can help mix oil and water together, will treat gut inflammation seen in Crohn's disease. This proposal aims to address the main research question: Are dietary emulsifiers associated with breakdown of the intestinal barrier and inflammation? We have designed a low and high emulsifier diet and we plan to conduct a human dietary trial to examine the effects of a low emulsifier diet in patients with Crohn's disease. Crohn's disease patients will receive either a low emulsifier or controlled diet for 4 weeks. At the end of diet period, subjects will give blood, urine and faecal samples, which will be analysed for markers of inflammation.

Interventions

Study 2 in patients with mild Crohn's disease - subjects will be randomised to either a low emulsifier diet, hypothesised to treat disease activity, or a controlled diet for 4 weeks. The controlled diet will be either the subjects' usual diet or a high emulsifier diet. The high emulsifier diet is matched nutritionally, but will use foods that contain emulsifiers. For example, two commercially available wholemeal breads that do and do not already contain emulsifiers will be provided during the

Study 2 in patients with mild Crohn's disease - subjects will be randomised to either a low emulsifier diet, hypothesised to treat disease activity, or a controlled diet for 4 weeks. The controlled diet will be either the subjects' usual diet or a high emulsifier diet. The high emulsifier diet is matched nutritionally, but will use foods that contain emulsifiers. For example, two commercially available wholemeal breads that do and do not already contain emulsifiers will be provided during the dietary interventions. Unfortunately, quantification of emulsifiers in food is not possible, so 'high' and 'low' emulsifier diets will describe foods that have identifiable sources of emulsifiers or not. The choice of controlled diet will depend on the results of Study 1 (UTN - U1111-1235-0246). A low emulsifier diet is developed by the researchers at The Alfred and based on knowledge of natural emulsifiers in addition to identified additive emulsifiers on packaged food. Researchers at The Alfred have a database of commercially available packaged food and their ingredients lists, which identify presence or absence of emulsifiers. Unfortunately, quantification of emulsifiers in food is not possible, so a low emulsifier diet describes foods that have no identifiable sources of emulsifiers on ingredients lists. Research dietitians will be recruiting and arranging all food for the intervention is provided to participants. The diets will comprise of food cooked, individually portioned, vacuum-packed and frozen by our research chef. Examples of meals may include a risotto or pasta dish. All food is readily available in supermarkets and already consumed by community. Adherence will be based on food diaries provided to participants and any returned food. If Study 1 indicates that a high emulsifier diet induces intestinal inflammation above baseline, the subjects' usual diet will be used as the controlled diet.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Study 2 - patients with mild Crohn's disease on stable medical therapy for at least 2 months. Severity of disease activity will be based on elevated disease activity index (Harvey Bradshaw Index) and/or elevated faecal calprotectin.

Exclusion criteria

Study 2 - peanut allergy, recent use (previous 2 weeks) of probiotics, antibiotics, supplemental prebiotics, restrictive diets (including vegetarian) or any medication including complimentary and alternative medicines that might influence gut function or microbiota, malnutrition, and/or psychological illness, or inability to speak or read English or give informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026