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Ketogenic Diet Prior to Bariatric Surgery

RecruitingNAAges 18 Years - 65 YearsAllMaxima Medical Center
NCT06850493 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Standard dietary regiments for bariatric are advised prior to surgery. The most used diet is a very low calorie diet (VLCD). These diets potentially have multiple pittfalls. Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Eligible for bariatric surgery (≥35 kg/m2 with obesity-related comorbidities, or a BMI of * 40 kg/m2 with or without comorbidities) * Roux-en-Y Gastric bypass (RYGB) 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 (\< 12 months), heart failure or cardiac arrhythmias * Kidney and/or liver failure (creatinine levels \>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 \<35, psychological or unstable psychiatric disorders, inadequate dietary regimen or inadequate exercise pattern which can't be resolved in the upcoming 6 months)
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What it tests

  • VLCKD (ketogenic diet)
  • VLCD (Very-low-calorie-diet)
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Where

1 site
Maxima Medical Center
Veldhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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