The study aim is to assess the feasability of an anti-inflammatory diet, as add-on treatment (next to standard medical treatment) in patients with active Crohn*s disease. We will study the effect of the diet on symptoms and quality of life. Also, we…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study period will last for 6 months, and the primary outcome measure will
be adherence to the diet and diet related quality of life.
Secondary outcome
* Symptoms (CDAI) (standard medical care)
* Fecal calprotectin at baseline, 3 and 6 months (standard medical care)
* C-reactive protein at baseline, 3 and 6 months (standard medical care)
* Health related quality of life, as measured using sIBDQ
* Nutritional status and anthropometry (body weight, hand grip strength)
* Diet quality (MDS-score) and food intake (3-day food diary)
* Fibroscan analysis to assess effect of the diet on liver fat content
* Waist hip ratio (as a marker for visceral adiposity)
* Fitmate analysis to make a personalized metabolic expenditure estimation
* BIVA analysis (baseline en 6 maanden)
* AGE reader (baseline en 6 maanden)
Background summary
Diet is important to patients with IBD and many patients ask whether eating the
right foods can make a difference in their disease. Although studies about
food and IBD are conflicting, the chronic inflammation, impaired intestinal
barrier function and microbial disturbances seen in IBD may be reduced by
appropriate nutrition. Most studies focussed on one aspect of the diet, such as
dietary fiber, carbohydrates, or probiotics. We propose to test a nutritional
intervention that combines foods and nutrients with proven or plausible
anti-inflammatory properties (referred to as MediterraneanPLUS (MedP)
anti-inflammatory diet).
Study objective
The study aim is to assess the feasability of an anti-inflammatory diet, as
add-on treatment (next to standard medical treatment) in patients with active
Crohn*s disease. We will study the effect of the diet on symptoms and quality
of life. Also, we will assess what components if the diet are and aren*t well
tolerated, and what are the patients* indicators of non-tolerance and
non-adherence.
Study design
Observational pilot study: anti-inflammatory diet as add-on treatment in active
Crohn*s disease.
Patient preference study design. Potential participants will be offered a
choice of joining the diet intervention or the control group. The control group
will entitle the same protocol, without referral to the dietician.
Study burden and risks
A potential issue of concern is that a change in diet will lead to loss in body
weight, which is potentially harmful during active Crohn*s disease. Therefore
the anti-inflammatory diet will be personalized. At the intake visit, metabolic
expenditure and food intake will be assed and a personalized (total amount of
calories advised) diet will be recommended. At every follow-up visit weight
will be recorded and if a patient loses weight, nutritional weight gain drinks
will be prescribed. Gaining weight is not considered a problem during active
Crohn*s disease
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
5.1 Population (base)
Patients with active luminal Crohn*s disease
5.2 Inclusion criteria
Patients >18 years, active luminal Crohn*s disease localized in colon and/ or terminal ileum, fecal calprotectin (fCAL) > 150 mg/g andSES-CD>5 or calpro >300 mg/g.
Exclusion criteria
Patients unable or unwilling to provide informed consent, stenosis associated with symptoms, contra-indications to starting biological or immunomodulatory agent. Additionally, the relative Mediterranean diet score will be calculated based on self-reported dietary intake by a food frequency questionnaire to exclude patients already using a Mediterranean-like diet.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL60573.058.17 |