Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria) |
Change in prevalence of malnutrition according to the GLIM criteria |
3 months after study enrollment |
|
Secondary |
Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria) |
Change in prevalence of malnutrition according to the ESPEN criteria |
3 months after study enrollment |
|
Secondary |
Skeletal Muscle Mass |
Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) |
3 months after study enrollment |
|
Secondary |
Fat Free Mass |
Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA) |
3 months after study enrollment |
|
Secondary |
Fat Mass |
Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA) |
3 months after study enrollment |
|
Secondary |
Total Body Water |
Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA) |
3 months after study enrollment |
|
Secondary |
Extracellular Water |
Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA) |
3 months after study enrollment |
|
Secondary |
Phase Angle |
Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA) |
3 months after study enrollment |
|
Secondary |
Body Weight |
Changes in body weight measured in kilograms |
3 months after study enrollment |
|
Secondary |
Height |
Changes in height measured in meters |
3 months after study enrollment |
|
Secondary |
Body Mass Index |
Changes in body mass index in kg/m^2 (calculated from the values obtained for body weight and height) |
3 months after study enrollment |
|
Secondary |
Waist Circumference |
Changes in waist circumference measured in centimeters |
3 months after study enrollment |
|
Secondary |
Hip Circumference |
Changes in hip circumference measured in centimeters |
3 months after study enrollment |
|
Secondary |
Waist-to-Hip Ratio |
Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference) |
3 months after study enrollment |
|
Secondary |
Upper Arm Circumference |
Changes in upper arm circumference measured in centimeters |
3 months after study enrollment |
|
Secondary |
Triceps Skinfold Thickness |
Changes in triceps skinfold thickness measured in millimeters |
3 months after study enrollment |
|
Secondary |
Muscle Strength |
Changes in muscle strength measured by a handgrip strength dynamometer |
3 months after study enrollment |
|
Secondary |
Muscle Function |
Changes in muscle function measured by a 4-m gait speed test |
3 months after study enrollment |
|
Secondary |
Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria) |
Change in prevalence of sarcopenia according to the EWGSOP2 criteria |
3 months after study enrollment |
|
Secondary |
Energy Intake |
Changes in energy intake assessed by 3-day weighed dietary record |
3 months after study enrollment |
|
Secondary |
Protein Intake |
Changes in protein intake (in g/day) assessed by 3-day weighed dietary record |
3 months after study enrollment |
|
Secondary |
Carbohydrate Intake |
Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record |
3 months after study enrollment |
|
Secondary |
Fat Intake |
Changes in fat intake (in g/day) assessed by 3-day weighed dietary record |
3 months after study enrollment |
|
Secondary |
Dietary Fiber Intake |
Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record |
3 months after study enrollment |
|
Secondary |
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 |
3 months after study enrollment |
|
Secondary |
Complete Blood Count |
Changes in complete blood count |
3 months after study enrollment |
|
Secondary |
Albumin |
Changes in plasma concentration of albumin |
3 months after study enrollment |
|
Secondary |
Aspartate Transaminase |
Changes in plasma concentration of aspartate transferase |
3 months after study enrollment |
|
Secondary |
Alanine Aminotransferase |
Changes in plasma concentration of alanine aminotransferase |
3 months after study enrollment |
|
Secondary |
Gamma-glutamyl Transferase |
Changes in plasma concentration of gamma-glutamyl transferase |
3 months after study enrollment |
|
Secondary |
Bilirubin |
Changes in plasma concentration of bilirubin |
3 months after study enrollment |
|
Secondary |
Creatinine |
Changes in plasma concentration of creatinine |
3 months after study enrollment |
|
Secondary |
Urea |
Changes in plasma concentration of urea |
3 months after study enrollment |
|
Secondary |
C-reactive Protein |
Changes in plasma concentration of C-reactive protein |
3 months after study enrollment |
|
Secondary |
Plasma Metabolome |
Changes in plasma metabolome |
3 months after study enrollment |
|
Secondary |
Plasma Transcriptome |
Changes in plasma transcriptome |
3 months after study enrollment |
|
Secondary |
Intestinal Microbiome |
Changes in intestinal microbiome |
3 months after study enrollment |
|