Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. However, there is only limited data on nutritional treatment. In this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. The aim of the study is that malnutrition in patients with chronic pancreatitis can be successfully treated.
Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to increased morbidity and mortality. Therefore nutritional therapy can be considered imperative. However, there is limited evidence on the treatment of malnutrition in patients with chronic pancreatitis. This study aims to investigate the effect of an intensified nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis. By testing feasibility of this intensified therapy valuable recommendations for future treatment of malnutrition in patients with chronic pancreatitis can be derived.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.
University Medicine Greifswald
Greifswald, Germany
RECRUITINGChanges in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria
Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months
Time frame: 6 months
Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria
Prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria
Time frame: 28 days, 3 months, 6 months
Dropout Rate
Dropout Rate
Time frame: 28 days, 3 months, 6 months
Compliance to Oral Nutritional Supplements
Compliance is assessed by a standardized telephone interview comparing recommended and current intake
Time frame: 28 days, 3 months, 6 months
Compliance to Dietary Counselling
Compliance is assessed via standardized telephone interview comparing scheduled and cancelled sessions
Time frame: 28 days, 3 months, 6 months
Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria
Prevalence of malnutrition according to the Global Leadership Initiative on Malnutrition criteria
Time frame: 28 days, 3 months, 6 months
Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria
Prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria
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Time frame: 28 days, 3 months, 6 months
Reduced Body Mass Index
Changes in prevalence of reduced body mass index (\< 18,5 kg/m², \< 20 kg/m² if age \< 70 yrs, \< 22 kg/m² if age ≥ 70 yrs)
Time frame: 28 days, 3 months, 6 months
Reduced Fat Free Mass Index
Changes in prevalence of reduced fat free mass index (≤ 15 kg/m² if female, ≤ 17 kg/m² if male)
Time frame: 28 days, 3 months, 6 months
Reduced Skeletal Muscle Mass Index
Changes in prevalence of reduced skeletal muscle mass index (≤ 6,42 kg/m² if female, ≤ 8,87 kg/m² if male)
Time frame: 28 days, 3 months, 6 months
Reduced Gait Speed
Changes in prevalence of reduced gait speed (\< 0,8 m/s)
Time frame: 28 days, 3 months, 6 months
Reduced Muscle Strength
Changes in prevalence of reduced muscle strength (\< 19,3 kg if female, \< 30,3 kg if male)
Time frame: 28 days, 3 months, 6 months
Body Weight
Changes in body weight measured in kilograms
Time frame: 28 days, 3 months, 6 months
Height
Changes height measured in centimeters
Time frame: 28 days, 3 months, 6 months
Body Mass Index
Changes in body mass index measured in kg/m\^2 (calculated from the values obtained for body weight and height)
Time frame: 28 days, 3 months, 6 months
Waist Circumference
Changes in waist circumference measured in centimeters
Time frame: 28 days, 3 months, 6 months
Hip Circumference
Changes in hip circumference measured in centimeters
Time frame: 28 days, 3 months, 6 months
Waist-to-Hip Ratio
Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)
Time frame: 28 days, 3 months, 6 months
Triceps Skinfold Thickness
Changes in triceps skinfold thickness measured in millimeters
Time frame: 28 days, 3 months, 6 months
Upper Arm Circumference
Changes in upper arm circumference measured in centimeters
Time frame: 28 days, 3 months, 6 months
Fat Free Mass
Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 28 days, 3 months, 6 months
Skeletal Muscle Mass
Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 28 days, 3 months, 6 months
Fat Mass
Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 28 days, 3 months, 6 months
Total Body Water
Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 28 days, 3 months, 6 months
Extracellular Water
Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 28 days, 3 months, 6 months
Phase Angle
Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 28 days, 3 months, 6 months
Energy Intake
Changes in energy intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
Time frame: 28 days, 3 months, 6 months
Protein Intake
Changes in protein intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
Time frame: 28 days, 3 months, 6 months
Carbohydrate Intake
Changes in carbohydrate intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
Time frame: 28 days, 3 months, 6 months
Fat Intake
Changes in fat intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
Time frame: 28 days, 3 months, 6 months
Dietary Fiber Intake
Changes in dietary fiber intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
Time frame: 28 days, 3 months, 6 months
Physical Activity
Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form
Time frame: 28 days, 3 months, 6 months
Hemoglobin
Changes in hemoglobin level
Time frame: 28 days, 3 months, 6 months
Hematocrit
Changes in hematocrit level
Time frame: 28 days, 3 months, 6 months
Mean Corpuscular Volume
Changes in mean corpuscular volume
Time frame: 28 days, 3 months, 6 months
Mean Corpuscular Hemoglobin Concentration
Changes in mean corpuscular hemoglobin concentration
Time frame: 28 days, 3 months, 6 months
Reticulocyte Count
Changes in reticulocyte count
Time frame: 28 days, 3 months, 6 months
Sodium
Changes in plasma concentration of sodium
Time frame: 28 days, 3 months, 6 months
Potassium
Changes in plasma concentration of potassium
Time frame: 28 days, 3 months, 6 months
Calcium
Changes in plasma concentration of calcium
Time frame: 28 days, 3 months, 6 months
Magnesium
Changes in plasma concentration of magnesium
Time frame: 28 days, 3 months, 6 months
Phosphate
Changes in plasma concentration of phosphate
Time frame: 28 days, 3 months, 6 months
Aspartate Transaminase
Changes in plasma concentration of aspartate transferase
Time frame: 28 days, 3 months, 6 months
Alanine Aminotransferase
Changes in plasma concentration of alanine aminotransferase
Time frame: 28 days, 3 months, 6 months
Gamma-glutamyl Transferase
Changes in plasma concentration of gamma-glutamyl transferase
Time frame: 28 days, 3 months, 6 months
Alkaline Phosphatase
Changes in plasma concentration of alkaline phosphatase
Time frame: 28 days, 3 months, 6 months
Bilirubin
Changes in plasma concentration of bilirubin
Time frame: 28 days, 3 months, 6 months
C-reactive Protein
Changes in plasma concentration of C-reactive protein
Time frame: 28 days, 3 months, 6 months
Interleukin-1 Beta
Changes in serum concentration of interleukin-1 beta
Time frame: 28 days, 3 months, 6 months
Interleukin-6
Changes in plasma concentration of interleukin-6
Time frame: 28 days, 3 months, 6 months
Tumor Necrosis Factor Alpha
Changes in serum concentration of tumor necrosis factor alpha
Time frame: 28 days, 3 months, 6 months
Albumin
Changes in plasma concentration of albumin
Time frame: 28 days, 3 months, 6 months
Creatinine
Changes in plasma concentration of creatinine
Time frame: 28 days, 3 months, 6 months
Urea
Changes in plasma concentration of urea
Time frame: 28 days, 3 months, 6 months
Uric Acid
Changes in plasma concentration of uric acid
Time frame: 28 days, 3 months, 6 months
Glucose
Changes in plasma concentration of glucose
Time frame: 28 days, 3 months, 6 months
Glycated hemoglobin
Changes in plasma concentration of glycated hemoglobin
Time frame: 28 days, 3 months, 6 months
Insulin
Changes in serum concentration of insulin
Time frame: 28 days, 3 months, 6 months
Total Cholesterol
Changes in plasma concentration of total cholesterol
Time frame: 28 days, 3 months, 6 months
High-density Lipoprotein Cholesterol
Changes in plasma concentration of high-density lipoprotein cholesterol
Time frame: 28 days, 3 months, 6 months
Low-density Lipoprotein Cholesterol
Changes in plasma concentration of high-density lipoprotein cholesterol
Time frame: 28 days, 3 months, 6 months
Triglycerides
Changes in plasma concentration of triglycerides
Time frame: 28 days, 3 months, 6 months
Non-essential Fatty Acids
Changes in plasma concentration of non-essential fatty acids
Time frame: 28 days, 3 months, 6 months
Zinc
Changes in serum concentration of zinc
Time frame: 28 days, 3 months, 6 months
Iron
Changes in plasma concentration of iron
Time frame: 28 days, 3 months, 6 months
Hand Grip Strength
Changes in maximal hand grip strength
Time frame: 28 days, 3 months, 6 months
Gait Speed
Changes in gait speed
Time frame: 28 days, 3 months, 6 months
Anxiety and Depression
Changes in anxiety and depression assessed by the German version of the Hospital Anxiety and Depression Scale (HADS-D). For both the anxiety and the depression subscale scores range from 0-21, with higher values indicating a worse outcome.
Time frame: 28 days, 3 months, 6 months
Fatigue
Changes in fatigue assessed by the German version of the Fatigue Severity Scale (FSS). Scores range from 1-7, with higher values indicating a better outcome.
Time frame: 28 days, 3 months, 6 months
Loneliness
Changes in loneliness assessed by the German Version of the 6-item De Jong Gierveld Loneliness Scale. Scores range from 0-6, with higher values indicating worse outcome.
Time frame: 28 days, 3 months, 6 months
Intestinal Microbiome
Changes in the intestinal microbiome
Time frame: 28 days, 3 months, 6 months
Plasma Metabolome
Changes in the plasma metabolome
Time frame: 28 days, 3 months, 6 months
Plasma Transcriptome
Changes in the plasma transcriptome
Time frame: 28 days, 3 months, 6 months