Ketogenic diet before bariatric surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a very low-calorie ketogenic diet (VLCKD) on patients preparing for bariatric surgery. It aims to compare the VLCKD with standard very low-calorie diets (VLCD) to assess weight loss and liver volume reduction while preserving lean body mass. The trial will involve a randomized controlled design to provide robust data on the efficacy of VLCKDs in this context. The study is motivated by the need for improved preoperative dietary regimens that can enhance surgical outcomes and reduce complications.

Why it matters

Who can join: the full rules

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)

Where it's running

• Maxima Medical Center
  Veldhoven, North Brabant, Netherlands Recruiting

Study contacts

• Principal investigator: Francois van Dielen, MD PhD — Maxima Medical Center
• Study coordinator: Aliyar Esfandiyari Noushi, MD
• Email: aliyar.esfandiyarinoushi@mmc.nl
• Phone: +31408888550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.