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Effects on disease activity, self-reported symptoms and microbiota profile in patients with inflammatory bowel disease of a modified anti-inflammatory diet.

Effects on disease activity, self-reported symptoms and microbiota profile in patients with inflammatory bowel disease of a modified anti-inflammatory diet.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001500145
Acronym
IBD MAID
Enrollment
5
Registered
2019-10-30
Start date
2020-09-25
Completion date
2021-08-30
Last updated
2021-05-10

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

Conditions

None listed

Brief summary

The aim of this study is to investigate the safety, feasibility and efficacy of an anti-inflammatory diet prescription to dampening inflammatory pathways, in conjunction with standard medical therapy, on disease activity, and the gut microbiota composition in individuals with mild to moderate disease.

Interventions

Following the completion of screening patients will be randomized to intervention arm or control arm. In the intervention arm patients will receive IBD-MAID (IBD modified anti-inflammatory diet) meals for lunch and dinner and advised on appropriate breakfast and snack options by the dietitian at a 1 hour face to face appointment. All meals provided and breakfast/snack options/recipes will align with IBD MAID guidelines (contain no artificial sweeteners, emulsifiers, cured/processed meats and mus

Following the completion of screening patients will be randomized to intervention arm or control arm. In the intervention arm patients will receive IBD-MAID (IBD modified anti-inflammatory diet) meals for lunch and dinner and advised on appropriate breakfast and snack options by the dietitian at a 1 hour face to face appointment. All meals provided and breakfast/snack options/recipes will align with IBD MAID guidelines (contain no artificial sweeteners, emulsifiers, cured/processed meats and must combine to meet the daily targets of pro-inflammatory diet constituents such as extra virgin olive oil, fruits, vegetables and wholegrains daily). Participants in the control group will see the dietitian face to face for a 1 hour appointment for general dietary advice (GDA) and be provided with recipes from the eat for health national campaign for the 8 week period. Baseline measures will be repeated at week 8 and participants will have a 1 week washout period before being crossed over to the intervention arm. After the 8 week intervention period all participants will be invited to continue following the IBD MAID diet for a further 10 months. Consenting participants will receive further IBD MAID education and counselling from the dietitian at the 8 week follow up 30-45 minute face to face appointment. Participants will have the contact details of the dietitian for support during the intervention period. The dietitian will also send participants new recipes monthly during the 10 month period and participants will be contacted monthly by the dietitian via telehealth or phone (~10 mins) to provide additional dietary support and guidance. IBD MAID dietary adherence will be assessed by an online 3 day food diary completed monthly and checklist of key dietary nutrients completed weekly.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Diagnosis of UC or CD established for at least 3 months prior to time of consent Mild to moderate disease activity at time of consent

Exclusion criteria

- Become pregnant or are currently pregnant or lactating - Current smokers or individuals who have ceased smoking within12 months prior to screening - Excessive ETOH consumption as defined as >2glasses per day - Multiple food allergies/intolerances which may affect ability to follow the diet prescription.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026