Ketogenic Diet Prior to Bariatric Surgery (NCT06850493) | Clinical Trial Compass
RecruitingNot Applicable
Ketogenic Diet Prior to Bariatric Surgery
Netherlands46 participantsStarted 2022-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in FFM (%) in proportion to TBWL
Timeframe: 2 weeks prior to surgery, day of surgery and 3 months after surgery