An interventional study of Mediterranean diet and Low residue diet in Crohn's Disease, sponsored by michal roll. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-07.
Sponsored by michal roll · Not applicable, Interventional, and Treatment
This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases.
The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →michal roll is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients with active Crohn's disease that will be allocated to the Mediterranean diet group.
Behavioral: Mediterranean diet
Patients with active Crohn's disease that will be allocated to the low residue diet group.
Behavioral: Low residue diet
Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).
Eight weeks course of low residue diet (minimal consumption of foods that add residue to the stool, such as raw fruits, vegetables and seeds, as well as nuts, legumes and whole grains).
Crohn's Disease Activity Index (CDAI)
Change from baseline
Time frame: 8 weeks
C-reactive protein
Change from baseline
Time frame: 8 weeks
Fecal calprotectin
Change from baseline
Time frame: 8 weeks
Remission rate- CDAI<150 + normal CRP/ fecal calprotectin
Time frame: 52 weeks
Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin
Time frame: 8 weeks
Microbial composition
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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