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Anti-inflammatory diet as add-on therapy in inflammatory bowel disease

Anti-inflammatory diet as add-on therapy in inflammatory bowel disease - INSIDE

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46158
Enrollment
30
Registered
2018-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

chronic inflammation of the colon inflammatory bowel disease

Interventions

The intervention will be an anti-inflammatory diet, rich in vegetables, fruits and grains, with small amounts of fish and dairy products. Tea and water are the preferred drinks. Red and processed me

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of Crohn's disease or ulcerative colitis (total or left-sided colitis) made by gastroenterologist and histologically proven - Between 18-75 years of age - Mild disease activity based on CDAI * 150 or SCCAI * 3 - Stable medical therapy for * 2 months - Signed informed consent

Exclusion criteria

Exclusion criteria: - Unwilling or unable to visit the Human Nutrition Research Unit five times per week during the intervention period - Unwilling to strictly follow a diet for four weeks - Participation in another intervention study - Adherence to a vegan lifestyle - Intending to make lifestyle changes during the duration of the study - History of total or partial bowel resection - Use of biologicals (e.g. infliximab, adalimumab, golumimab, ustekinumab, vedolizumab) - More supplement use than the recommended dietary allowance - Not allowing to inform the treating gastroenterologist about the participation - Being an employee or student of Wageningen University, division of Human Nutrition and Health

Design outcomes

Primary

MeasureTime frame
The main study parameter is inflammation measured by faecal calprotectin at the beginning and end of each period. Lower values represent less or absence of inflammation.

Secondary

MeasureTime frame
Secondary parameters are clinical disease activity measured by the Crohn's Disease Activity Index (CDAI) in Crohn's disease and the Simple Clinical Colitis Activity Index (SCCAI) in ulcerative colitis, inflammatory markers in blood (CRP, cytokines, whole blood count, ferritin and albumin) and quality of life measured by Inflammatory Bowel Disease Questionnaire (IBDQ).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)