Randomized Trial of Preoperative Diets Before Bariatric Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Lievensberg Ziekenhuis.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
R. Schouten, Lievensberg Ziekenhuis
ClinicalTrials.gov Identifier:
First received: July 25, 2012
Last updated: August 6, 2012
Last verified: August 2012
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

Condition Intervention
Morbid Obesity
Bariatric Surgery
Gastric Bypass
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Lievensberg Ziekenhuis:

Primary Outcome Measures:
  • Preoperative weight loss before bariatric surgery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Weight loss in kg before operation

Secondary Outcome Measures:
  • - operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Measured by VAS, diet books and questionnaires

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet
New developed diet
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
Active Comparator: Prodimed
Standard VLCD
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • morbid obesity according to IFSO criteria

Exclusion Criteria:

  • previous bariatric or gastric surgery
  • severe psychiatric disorders
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01652105

Contact: Ruben Schouten, Md, PhD schoutenruben@hotmail.com

Bariatric Centre Lievensberg hospital Not yet recruiting
Bergen op Zoom, Netherlands, 4624 VT
Contact: Ruben Schouten, Md, PhD       schoutenruben@hotmail.com   
Sponsors and Collaborators
Lievensberg Ziekenhuis
  More Information

Responsible Party: R. Schouten, MD, PhD, Lievensberg Ziekenhuis
ClinicalTrials.gov Identifier: NCT01652105     History of Changes
Other Study ID Numbers: rubenschouten1 
Study First Received: July 25, 2012
Last Updated: August 6, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Lievensberg Ziekenhuis:
Gastric bypass
Preoperative diet

Additional relevant MeSH terms:
Obesity, Morbid
Body Weight
Nutrition Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016