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Search / Trial NCT06850493

Ketogenic Diet Prior to Bariatric Surgery

Launched by MAXIMA MEDICAL CENTER · Feb 24, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a very low-calorie ketogenic diet (VLCKD) for people who are preparing for bariatric surgery, specifically the Roux-en-Y gastric bypass. The goal is to see if this diet can help patients lose weight and reduce liver size while preserving muscle mass. This is important because traditional very low-calorie diets can lead to muscle loss, which we want to avoid. By participating in this trial, individuals may contribute to important research that could improve pre-surgery diets for future patients.

To be eligible for the trial, participants must be candidates for bariatric surgery, meaning they generally have a body mass index (BMI) of 35 or higher, along with related health issues, or a BMI of 40 or higher. The trial is open to adults aged between 18 and 75, and all genders are welcome. However, there are some exclusions, such as individuals with certain medical conditions or those who weigh more than 150 kg. If you join this trial, you can expect to follow a specific diet plan and be monitored closely to assess its effects on your health as you prepare for surgery. This research could help us understand the best dietary approaches before bariatric surgery.

Gender

ALL

Eligibility criteria

  • 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)

About Maxima Medical Center

Maxima Medical Center is a leading healthcare institution dedicated to advancing medical knowledge and improving patient care through innovative clinical research. With a commitment to excellence, the center conducts a diverse range of clinical trials across various therapeutic areas, collaborating with healthcare professionals and researchers to facilitate the development of new treatments and therapies. Maxima Medical Center prioritizes patient safety and ethical standards, ensuring that all clinical studies adhere to rigorous regulatory requirements. By fostering a culture of collaboration and innovation, the center aims to contribute significantly to the medical community and enhance the quality of life for patients.

Locations

Veldhoven, Noord Brabant, Netherlands

Patients applied

0 patients applied

Trial Officials

Francois van Dielen, MD PhD

Principal Investigator

Maxima Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported