Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06850493

Ketogenic Diet Prior to Bariatric Surgery

Led by Maxima Medical Center · Updated on 2025-02-27

46

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ketogenic Diet Prior to Bariatric Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible for bariatric surgery with a BMI of 35 or higher plus obesity-related health problems, or BMI of 40 or higher with or without health problems
  • Scheduled for Roux-en-Y gastric bypass surgery
Not Eligible

You will not qualify if you...

  • Weighing over 150 kilograms due to device limitations
  • Having type 1 diabetes
  • Allergic to milk proteins
  • Recent heart attack within 12 months, heart failure, or irregular heartbeats
  • Kidney or liver failure with certain abnormal lab values
  • Current infection, sepsis, or cancer
  • Rare metabolic conditions like galactosemia, phenylketonuria, or porphyria
  • Persistent diarrhea
  • Low potassium levels or ongoing treatment with certain diuretics
  • Pregnancy or plans to become pregnant soon
  • Not meeting bariatric surgery criteria due to BMI under 35, psychological or psychiatric disorders, or unresolved diet or exercise issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Maxima Medical Center

Veldhoven, North Brabant, Netherlands, 5500MB

Actively Recruiting

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Research Team

A

Aliyar Esfandiyari Noushi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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