Malnutrition Clinical Trial
— CEDERN-1Official title:
Influence of Disease Activity of Inflammatory Bowel Disease on Resting Energy Expenditure and Nutritional Status
Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in
IBD is often limited by chronic inflammation, but is also commonly reduced by missing
intestinal segments due to previous operations. Patients are predominantly affected by
malnutrition, which is often resembled by weight loss, specific micronutrient deficits such
as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and
zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively
limited to active phases of the disease. Causes of malnutrition can be inadequate food
intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition
itself is associated with a delayed recovery of impaired wound healing, reduced quality of
life and longer hospital stays. Therefore, observation and modification of the nutritional
status should be an integral part of therapy in IBD patients.
The primary objective of our study is to investigate the influence of the disease on the
resting energy expenditure and nutritional status during acute inflammation and clinical
remission of the disease. Secondary objectives are to assess possible nutritional
deficiencies. On the other hand it is well known that patients with IBD are at increased
risk for coronary heart disease. Therefore, another secondary focus of our observational
study is whether the composition of the HDL proteins is changed towards pro-atherogenic
HDL-proteins and whether possible changes occur in patients in clinical remission or with
active disease.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - inflammatory bowel disease - male and female between 18-80 years - patient fully able to understand the study concept and to give his or her written consent Exclusion Criteria: - underlying malignant disease - Diabetes mellitus, Type I or II - Pregnancy - Lactating - chronic alcohol or drug abuse - known anorexia nervosa or binge eating disorder - known metabolic disorders, such as e.g. Cushing disease, hypothyroidism - Participation in other interventional studies within the last 6 months prior to study enrollment - patient not fully able to understand the study concept and to give his or her written consent |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Muenster | Muenster |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | change in fecal Calprotectin level | day 1, every 6 month up to 12 month | No | |
Other | change in live quality questionnaire | Gastrointestinal Quality of Life Index by Eypasch | day 1, every 6 month up to 12 month | No |
Primary | change in bioelectrical impedance analysis (BIA) | e.g. fat free mass, total body water, body cell mass | change from baseline in BIA at 6 month and at 12 month | No |
Primary | Change in resting energy expenditure (REE) | Resting energy expenditure measured by indirect calorimetry (kcal per day) | change from baseline in REE at 6 month and at 12 month | No |
Secondary | change in HDL subgroup analysis | day 1, every 6 month up to 12 month | No | |
Secondary | change in plasma citrulline level | day 1, every 6 month up to 12 month | No | |
Secondary | change in plasma vitamine levels and plasma zinc level | Vitamin B12, Vitamin K, Vitamin D | day 1, every 6 month up to 12 month | No |
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