Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Maxima Medical Center
Veldhoven, North Brabant, Netherlands, 5500MB
Actively Recruiting
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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