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The Impact of a Preoperative Very Low Calorie Ketogenic Diet on Body Composition in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
Led by Maxima Medical Center · Updated on 2025-02-27
46
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obesity rates have increased significantly worldwide, leading to serious health risks like type 2 diabetes, heart disease, and certain cancers. Bariatric surgery is considered the most effective treatment for severe obesity, improving long-term weight loss and related health issues. However, surgery can be technically challenging due to fat around the abdomen and liver size, so losing weight before surgery is often recommended to improve outcomes. This trial evaluates a very low-calorie ketogenic diet (VLCKD) compared to a very low-calorie diet (VLCD) before bariatric surgery to study their effects on body composition and metabolic rate. The study compares two dietary plans given for 14 days before surgery. One group follows a VLCD with meal sachets totaling under 800 kcal daily, including 50-60 grams of carbohydrates and 42-51 grams of protein, along with raw vegetables and clear soups. The other group follows a VLCKD consisting of six meal sachets daily with under 800 kcal, about 50 grams of carbohydrates, and 100 grams of protein, plus low-glycemic vegetables. Both diets aim to reduce fat mass while preserving lean body mass and resting metabolic rate. Participants will be monitored before surgery, on surgery day, and three months after surgery. Assessments include body composition changes, weight, physical activity, patient satisfaction, side effects, diet compliance, muscle strength, surgical outcomes, and extensive biochemical testing. Researchers will track changes in fat free mass relative to total body weight loss as the main outcome, along with other clinical and safety measures throughout the study period.
CONDITIONS
Brief Title
Ketogenic Diet Prior to Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for bariatric surgery with BMI 6535 kg/m2 with obesity-related health issues, or BMI 6540 kg/m2 with or without health issues
- Scheduled for Roux-en-Y Gastric bypass (RYGB) surgery
- Aged between 18 and 65 years
You will not qualify if you...
- Weighing over 150 kg due to DXA device limitations
- Diagnosis of type 1 diabetes mellitus
- Allergy to milk proteins
- Recent heart attack within 12 months, heart failure, or cardiac arrhythmias
- Kidney or liver failure with creatinine >1.3 mg/dl or liver enzymes (AST, ALT, GGT) more than three times above normal
- Current infectious, sepsis, or malignant disease
- Rare metabolic conditions such as galactosemia, phenylketonuria, or porphyria
- Persistent diarrhea
- Low potassium levels or chronic use of diuretics like furosemide or hydrochlorothiazide
- Pregnancy or planning pregnancy in the next months
- Not meeting bariatric surgery criteria due to BMI <35, psychological or unstable psychiatric disorders, or unresolved dietary or exercise issues within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants follow either a very low calorie ketogenic diet (VLCKD) or a very low calorie diet (VLCD) for weight loss prior to bariatric surgery.
Daily adherence to diet for 14 days prior to surgery
Duration - Day of surgery up to discharge
Participants undergo bariatric surgery and receive immediate post-operative care during their hospital stay.
Hospital admission for surgery and post-operative care
Duration - 3 months
Participants are monitored for outcomes including body composition, weight, physical activity, biochemical tests, and surgical recovery for 3 months after surgery.
Visits at day of surgery and at 3 months after surgery
Trial Site Locations
Total: 1 location
1
Maxima Medical Center
Veldhoven, North Brabant, Netherlands, 5500MB
Actively Recruiting
Research Team
A
Aliyar Esfandiyari Noushi, MD
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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