Ketogenic Diet Prior to Bariatric Surgery

Recruiting now · Not applicable

Conditions studied: Bariatric Surgery Candidate, Ketogenic Dieting

In brief

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.

Key facts

Study ID

NCT06850493

Run by

Maxima Medical Center

People needed

46

Starts

2022-09-01

Expected to finish

2025-12-01

Last updated by the study team

2025-02-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Maxima Medical Center — Veldhoven, North Brabant, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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