Randomized Trial of Preoperative Diets Before Bariatric Surgery

Study Overview
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Brief Summary
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Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

Detailed Description
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Morbid obesity, defined as a body mass index (BMI) of > 40 kg/m² or > 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of > 40 kg/m² and another 10 million people have a BMI of > 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities. In order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population.

Official Title
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Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial

Conditions
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Morbid Obesity, Bariatric Surgery, Gastric Bypass

Intervention / Treatment
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* Dietary Supplement: Standard diet versus standard VLCD (Prodimed)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: morbid obesity according to IFSO criteria Exclusion Criteria: previous bariatric or gastric surgery severe psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br>New developed diet | Dietary Supplement: Standard diet versus standard VLCD (Prodimed)<br> <br> |
| Active Comparator: Prodimed<br>Standard VLCD | Dietary Supplement: Standard diet versus standard VLCD (Prodimed)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative weight loss before bariatric surgery | Weight loss in kg before operation | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients | Measured by VAS, diet books and questionnaires | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric bypass, Preoperative diet, Prodimed