obesitas Morbid obesity
Conditions
Interventions
Control group:
The control group will receive the regular VLCD (standard care), two weeks
prior to their scheduled RYGB
Intervention group:
The intervention group will receive the VLCKD, two weeks p
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients with the age of 18-65 years are included if they are scheduled for a primary laparoscopic Roux-en-Y gastric bypass (RYGB) because of severe obesity. The latter is classified as a body mass index (BMI) of >=35 kg/m2 with obesity-related comorbidities, or a BMI of >=40 kg/m2 with or without comorbidities
Exclusion criteria
Exclusion criteria: • Weighing over 150kg because this amount is a limitation by the DXA device • Diabetes mellitus type 1 • Allergic to milk proteins • A recent history of a heart attack (1.3 mg/dl or liver enzyme levels (AST, ALT, GGT) less than three times over the upper normal threshold • Current infectious, sepsis or malignant disease • Rare condition like galactosemia, phenylketonuria or porphyria • Persistent diarrhoea • Hypokalaemia, chronic therapies with diuretics as furosemide and hydrochlorothiazide • Pregnancy or plans to get pregnant in the coming months • Patients who did not meet criteria to be eligible for bariatric surgery (BMI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction in FFM expressed in percentages in proportion to total body weight loss, from baseline to 2 weeks after start of the diet, as confirmed by multifrequency (MF) BIA and by Dual-energy X-ray Absorptiometry (DXA). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Weight, measured by MF-BIA and DXA • Body composition (FM, LBM and RMR) • Total body weight loss • Muscle strength, measured by handgrip peak strength • Compliance, side effects and food intake, measured by self-reported questionnaires and interviews • Surgical outcomes including surgical time, hospital stay, complications and re-admissions occurring within 30 days postoperative • Biochemical tests including B-hydroxybutyrate, albumin, electrolytes (sodium, potassium), liver function (AST = Aspartate Aminotransferase, ALT = Alanine Transaminase, GGT = gamma glutamyl transpeptidase), kidney function (creatinine, urea, eGFR), iron and hemoglobin, metabolic profile (total cholesterol, LDL = low-density lipoprotein, HDL= HDL*high-density lipoprotein, triglycerides), calcium, glucose. • Physical activity, measured by International Physical Activity Questionnaire (IPAQ) • Patient satisfaction (5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied) | — |
Countries
Netherlands
Outcome results
None listed