The primary objective is to assess the effect of an anti-inflammatory diet as add-on therapy on faecal calprotectin in patients with inflammatory bowel disease. Secondary objectives will be to assess the effect of the diet on clinical disease…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Several studies have tried to improve clinical outcomes in IBD by modifying the
diet. Most studies have been unsuccessful, probably due to the focus on single
foods or nutrients, such as dietary fibre, fatty acids or dairy, instead of the
whole diet. We propose to use a different approach: minimizing the inflammatory
potential of the diet by choosing foods and nutrients which have shown
anti-inflammatory properties in observational and intervention studies.
Study objective
The primary objective is to assess the effect of an anti-inflammatory diet as
add-on therapy on faecal calprotectin in patients with inflammatory bowel
disease. Secondary objectives will be to assess the effect of the diet on
clinical disease activity, inflammatory markers in blood and quality of life.
Study design
This study will have a one group pretest-posttest design. We propose to perform
a 4-week intervention study preceded by a 4-week run-in period and followed by
a 4-week follow-up period. All foods and drinks will be provided during the
intervention period. Study subjects will follow their habitual diet during
run-in and follow-up periods.
Intervention
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 meat, soft drinks and other processed
foods will be avoided.
Study burden and risks
Subjects need to visit the research unit 24 times, 4 times for measurements and
20 times to have dinner and receive other meals packaged for consumption at
home in the 4-week intervention period. During the 4 measurement visits, blood
samples will be taken and subjects need to fill in questionnaires (CDAI/SCCAI,
IBDQ). For these four visits they are asked to bring a faecal sample and at the
first and last visit they also need to fill in a FFQ. During every 4-week
period, subjects are asked to fill in a 24-hour dietary recall three times, so
9 times in total. Since the investigational treatment of this study consists of
daily used and freely available food products, there are no direct risks for
the subjects.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67452.081.18 |