RecruitingNot ApplicableNCT06850493

Ketogenic Diet Prior to Bariatric Surgery

The Impact of a Preoperative Very Low Calorie Ketogenic Diet (VLCKD) on Body Composition in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial


Sponsor

Maxima Medical Center

Enrollment

46 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • Eligible for bariatric surgery (≥35 kg/m2 with obesity-related comorbidities, or a BMI of
  • kg/m2 with or without comorbidities)
  • Roux-en-Y Gastric bypass (RYGB)

Exclusion Criteria11

  • 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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Interventions

DIETARY_SUPPLEMENTVLCKD (ketogenic diet)

diets prior to bariatric surgery

DIETARY_SUPPLEMENTVLCD (Very-low-calorie-diet)

diets prior to bariatric surgery


Locations(1)

Maxima Medical Center

Veldhoven, North Brabant, Netherlands

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NCT06850493


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