inflammation of the gastrointestinal tract inflammatory disease
Conditions
Interventions
This study will investigate a (cyclic) calorie restriction/protein restriction
(CRPR) diet, consisting of 70% of the individual*s required calories and ~20%
of the individual*s protein requirement,
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. - The subjects signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. - Crohn*s disease or Ulcerative colitis - Active mild to moderate disease (defined as an endoscopic SES-CD score >= 6 or in case of exclusive ileal disease >= 4, after ileocoecal resection a Rutgeert* score >= i2 and a HBI score between 5 and 10) or in case of UC a Mayo endoscopic sub score >= 1 with a Full MAYO-score between 4 and 9) - Age between 18 - 70 years at baseline - In the opinion of the investigator, the subject is capable of understanding in reading and speaking the Dutch language and complying with protocol requirements.
Exclusion criteria
Exclusion criteria: - BMI: 35 - Weight loss of >5% within one month or >10% within 6 months prior to the study - Use of pro- and antibiotics in 6 weeks prior to start of the study - Known allergy/intolerance to any of the ingredients in the diets - Known malignancy or dysplasia - Pregnancy, lactation -Risk of malnutrition as determined by renal insufficiency, renal or electrolyte abnormality (serum creatinine >2 × upper limit of normal (ULN); eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission induction (4 weeks of dietary intervention) - Proportion of patients with clinical remission after 4 weeks of dietary intervention. Clinical remission will be defined as a Harvey Bradshaw Index (HBI) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients with clinical response. Clinical response will be defined as HBI reduction >= 3. - Feasibility; proportion of patients that have maintained the diet throughout the trial period, combined with the compliance. Feasibility will be defined as >70% adherence to the protocol (based on known drug adherence rates in this study group, which is 66%). Compliance to the diet will be assessed by serum (pro)-albumin, urea and retinol binding protein. - Proportion of patients with biochemical remission. Biochemical remission will be defined as CRP | — |
Countries
Netherlands
Outcome results
None listed