Randomized Trial of Preoperative Diets Before Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01652105
Recruitment Status : Unknown
Verified August 2012 by R. Schouten, Lievensberg Ziekenhuis.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2012
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
R. Schouten, Lievensberg Ziekenhuis

July 25, 2012
July 27, 2012
August 7, 2012
September 2012
March 2013   (Final data collection date for primary outcome measure)
Preoperative weight loss before bariatric surgery [ Time Frame: 2 weeks ]
Weight loss in kg before operation
Same as current
Complete list of historical versions of study NCT01652105 on Archive Site
- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients [ Time Frame: 2 weeks ]
Measured by VAS, diet books and questionnaires
Same as current
Not Provided
Not Provided
Randomized Trial of Preoperative Diets Before Bariatric Surgery
Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial
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

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
  • Morbid Obesity
  • Bariatric Surgery
  • Gastric Bypass
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
  • Experimental: Diet
    New developed diet
    Intervention: Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
  • Active Comparator: Prodimed
    Standard VLCD
    Intervention: Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • morbid obesity according to IFSO criteria

Exclusion Criteria:

  • previous bariatric or gastric surgery
  • severe psychiatric disorders
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
R. Schouten, Lievensberg Ziekenhuis
Lievensberg Ziekenhuis
Not Provided
Not Provided
Lievensberg Ziekenhuis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP